Senior Design Quality Engineer Resume Sample
Lindsey Trantow
99066 Kunde Club,
Detroit,
MI
+1 (555) 994 1619
Work Experience
Senior Design Quality Engineer
10/2015
-
PRESENT
Los Angeles, CA
- Work with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed product, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, or performance
- Evaluates product design and identifies potential design quality issues and drive technical decisions
- Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements
- Assists on-time completion of Design Control Deliverables
- Accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations and internal requirements
- Prepares risk management files and report for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization
- Supports design test and inspection method development and validation
Senior Design Quality Engineer, Advanced
11/2012
-
09/2015
Philadelphia, PA
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
- Ensures DHF and DMR content completion, integrity, and regulatory standards compliance; collaboratively communicating resolving gaps
- Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Supports in the development and maintenance of Quality Management System procedures
- Support audits, CAPA/NCR/SCAR investigations and reports
Senior Design Quality Engineer APV
02/2010
-
10/2012
Chicago, IL
- Medical or Pharmaceutical industry experience
- Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
- Good statistical data analysis skills
- Manage multiple projects across multiple geographies
- Excellent verbal and written skills
- Able to work independently, as well as in a team environment
- Customer focused and service oriented
- Educate stakeholders, customers and management
- Interface with internal customers, suppliers and regulatory agencies
Education
Clark University
2005 - 2010
Engineer's Degree in Engineering
Professional Skills
- Strong quality engineering skills with a proven track record in process validation and failure mode effects and analysis is also required
- Strong Influence Skill, Presentation Skill and Dispute solving Skills
- Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
- Good verbal and written communication skills, including presentation skills
- Strong engineering skills with working knowledge of: Design and Process validation/verification activities are an asset
- Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired
- Experience with manufacturing quality control is a strong preference
How to write Senior Design Quality Engineer Resume
Senior Design Quality Engineer role is responsible for engineering, design, analysis, conflict, manufacturing, training, integration, database, auditing, refining.
To write great resume for senior design quality engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Design Quality Engineer Resume
The section contact information is important in your senior design quality engineer resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Senior Design Quality Engineer Resume
The section work experience is an essential part of your senior design quality engineer resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous senior design quality engineer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior design quality engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Design Quality Engineer resume experience can include:
- Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerancing (GD&T) is required
- + Experienced working with cross-functional and international teams
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset
- Do initial screening/validation of ecstatically test
- Work experience is required, preferably within a regulated environment (e.g. FDA regulated, Aerospace, Automotive)
- Skilled with inspection methods and techniques is required
Education on a Senior Design Quality Engineer Resume
Make sure to make education a priority on your senior design quality engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior design quality engineer experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Senior Design Quality Engineer Resume
When listing skills on your senior design quality engineer resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical senior design quality engineer skills:
- Solid oral, presentation and technical writing skills
- Highly effective communication, facilitation, coaching, and negotiation skills
- Solid interpersonal, organizational and project management skills
- Experience in Quality Engineering with experience in software quality
- Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis
- Experience of verification/validation test plan development and root cause failure analysis
List of Typical Experience For a Senior Design Quality Engineer Resume
1
Experience For Senior Design Quality Engineer, Advanced Resume
- Computer skills (MS Office products)
- Particular experience with product models including linked applications on mobile devices as well as large distributed systems such as SAP
- Experience with/Knowledge of: 21 CFR820, ISO13485:2016, euMDD/ euMDR, ISO14971: 2007/ 2012 and medical device manufacturing
- Lead Software tool validation and SOUP analysis
- Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis)
- Generate, approve and/or manage design verification and validation activities
- Evaluate solder joints on Harman PCBA after reflow, wave or select wave to validate production lines
2
Experience For Senior Design Quality Engineer New Product Development Resume
- Evaluate solder joints in Harman units after validation test to assess solder joint reliability
- Support and conduct process verification and validation activities
- Identifies quality characteristics and validation criteria for test methods, components, subassemblies, and finished devices
- Understanding of common software evaluation methods such as Code review, static analysis, state machine testing, Software FMEA, etc
- Support Manufacturing Engineering in the creation of travelers, routers, bills of material, print changes, and specifications for in-house manufacturing
- Provide training to project teams on procedures, statistical methods and design controls
- Supports Regulatory Affairs by providing quality input for notified body submissions or follow up queries
- Assist in the development of high level and departmental SOP’s governing or associated with design control activities/compliance
3
Experience For Senior Design & Quality Engineer Resume
- Plan, coordinate, execute and lead design verification testing against product requirement specifications
- Deal with adversity and find creative solutions to design and testing obstacles
- + Knowledge of FDA and TUV requirements
- + Travel up to 20-30%
- The ability to work independently and partner with a cross-functional team is required
- ASQ certifications are an asset
- Excellent written and oral communication skills are required. The ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required
4
Experience For Senior Design Quality Engineer APV Resume
- Represents the QA function on a cross functional team member supporting new product development
- Assesses overall product risk by facilitating the development of risk management tools such as Fault tree analysis, failure mode and effects analysis(FMEAs), failure mode, effect and criticality analysis (FMECAs) and contribute to the completion of the overall product risk management file
- Contributes to the successful completion of Process Validation initiatives by overseeing the process validation plan and the qualification activities required to meet validation requirements,
- Contribute to the successful completion of design (electrical, mechanical and software) verification and validation by participating in the product specification development, test method planning and validation, test execution and reporting
- Monitors supplier performance and initiates corrective actions as required
- Develop part qualification plans and oversees the production part approval process for mechanical parts, electronic assemblies and contract manufactured electro-mechanical assemblies
- Mentor other discipline as need in the Quality Engineering methodology
- Hands on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing
5
Experience For Senior Design Quality Engineer Resume
- Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks
- Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives
- Contributes to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products
- Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team
- Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications
- Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements
6
Experience For Senior Design Quality Engineer, Advanced Resume
- Knowledge of GD&T and applying associated inspection techniques
- Comply with applicable FDA and international regulatory laws/standards and the Cooper’s Code of Conduct
- Thorough knowledge of statistics and how to apply, evaluate, and provide recommendation from the data
- Represent Cooper as needed in FDA, notified body, internal, and other audits
- Extensive knowledge and expert of quality tools
- Resident expert of statistical techniques
- Recognize problems and proactively take corrective measures
- Facilitate and manage Software FMEA across various subsystems within the Minimally Invasive Surgical System, as per ISO 14971, IEC 62304, IEC 80002-1
- Ensure the adequacy of software design quality for a Minimally Invasive Surgical System, including test design, protocol and results review and other supporting quality evidence
7
Experience For Senior Design Quality Engineer New Product Development Resume
- Drive cross functional cybersecurity analysis effort
- Participate in Defect / Issue Management and Change Control Boards, as appropriate
- Participate in requirement review, verification test design
- Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
- Ensure all FDA and ISO verification validation requirements are met and for the review and approval of all Software protocols (e.g. embedded, controls, C/C++)
- Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative products
- Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements
8
Experience For Senior Design & Quality Engineer Resume
- Maintain appropriate communication channels with system level QA functions and management
- Support the ODM in translation of system requirements into module and component requirements
- Define a V&V plan, based on inputs from designer to translate into the capabilities of the ODM
- Follow-up on the V&V activities at the ODM supplier and report outcome clearly
- Check on proper execution of the tests and correct/request re-test where needed
- Align with ODM test engineers in Chinese
9
Experience For Senior Design Quality Engineer APV Resume
- Do initial alignment with DEKRA on approbation plan, based on compliance protocol
- Coordinate approbation locally, based on knowledge of when and who to supply with right documents and material at the approbation house
- First line of contact for all quality activities at supplier
- Together with the other local Philips contacts act as Philips liaison at supplier
- Lead major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems
- Lead/support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
- Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485
- Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, and ASTM E2500-07 Verification Guideline)
10
Experience For Senior Design Quality Engineer Resume
- Product Development team member focused on new product development activities
- Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies
- Conduct and lead design/process failure mode effects and analysis
- Conduct assessments of new suppliers as part of project teams
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc
- Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
- Create risk management plans, perform product risk assessments, facilitate the failure mode effects analysis, and create a final risk management report
List of Typical Skills For a Senior Design Quality Engineer Resume
1
Skills For Senior Design Quality Engineer, Advanced Resume
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
- Experience leading Process Verification / Validation activities is required
- Experience in the facilitation of effective DFMEAs/DFMECAs for complex electromechanical systems
- Strong design control and new product development experience
- Proven track record as a change leader is a strong preference
- Working knowledge of statistical methods, design history file contents and evidence, and risk management practices
- Understanding of Design Verification/Validation
- Demonstrated proficiency in decision making – preferably across a broad spectrum of Quality Engineering responsibilities
- Good understanding of material and processes involving development and evaluation of reagents
2
Skills For Senior Design Quality Engineer New Product Development Resume
- Engineering experience in medical devices
- BSc Mechanical engineering or related discipline with 5 years’ experience in a similar role
- Experience in product system level evaluation & testing
- Experienced working with cross-functional and international teams
- Experience with Geometric Dimensional and Tolerancing (GDT)
- 4+ experience in engineering
3
Skills For Senior Design & Quality Engineer Resume
- Direct experience with electro-mechanical equipment required, including IEC 60601, EMC and UL requirements
- Experience conducting Process / Design Failure Mode Effects and Analysis is required
- Experience in the application of design controls and risk management in an IVD or Medical device industry
- Strong familiarity with regulatory and other requirements (e.g., ISO 13485, ISO 14971, 21 CFR Part 11, 21 CFR 820, ISO 62304)
- Experience in risk evaluation techniques, such as PRA (Product Risk Assessment), FMEA, and fault tree analysis
- Experience in the evaluations of solder joint quality and reliability
- Experience in a large variety of electronic components
- Experience in solder joint evaluations
- Have experience in medical industry
4
Skills For Senior Design Quality Engineer APV Resume
- Experience in a regulated environment (FDA, ISO, etc.)
- Experience with design controls in Software Development environment is required
- Related working experience in a GMP and/or ISO regulated industry is required
- Ultrasound product experience
- Relevant job or academic experience
- Standing / Sitting / Walking
5
Skills For Senior Design Quality Engineer Resume
- Understanding of electronics assembly processes (reflow, wave soldering, Select wave, etc.)
- + Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
- A quality engineering certification from the American Society for Quality, or other qualifying organization. Examples include the CQE, CRE, etc
- + Collaborates with engineering and manufacturing functions to ensure quality standards are in place
- In Quality Engineering
6
Skills For Senior Design Quality Engineer, Advanced Resume
- Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes
- Develop understanding of current product to assist with product updates and maintenance releases
- Assist with creating Essential Requirements Checklists and Technical Files for EU submissions
- Find the improvement opportunity during project quality assurance and initialize the improvement
- Provide the process training to required trainees
- Work closely with suppliers on the qualification of new parts and processes supporting product development as needed
- Provide support to Operations teams to ensure successful transfer of the design and design controls to manufacturing
- Support continuous improvement activities including CAPA
7
Skills For Senior Design Quality Engineer New Product Development Resume
- + Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
- High level of autonomy and critical thinking is required. Teamwork oriented
- Clean driving record – ability to travel as required
- Evaluate Printed Circuit Board Assemblies with various lab tools according to IPC or customer spec
- Perform analyses of suspect solder joint; electronic component, and PCBA with a variety of lab tools, including
8
Skills For Senior Design & Quality Engineer Resume
- Provides leadership in the understanding of Medical Device (21 CFR 820) and HCTP (21 CFR 1271) regulations to other disciplines
- Actively represent Quality Engineering function on product development teams
- Quality System Knowledge; Interpret and apply relevant regulations and standards for products and processes (IEC, FDA, ISO etc.)
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources
- Design prototype and debug solutions of simple complexity
- Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)
- Experience with vascular devices, embolic coils, stents, catheters, balloons, and aspiration devices
- Experience Risk Management ISO 14971
9
Skills For Senior Design Quality Engineer APV Resume
- ‘Can Do’ attitude with continuous improvement mindset
- DFSS or DMAIC Black Belt Certified
- Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
- Manage multiple projects across multiple geographies
- Educate stakeholders, customers and management
- Interface with internal customers, suppliers and regulatory agencies
10
Skills For Senior Design Quality Engineer Resume
- Knowledge of FDA and TUV requirements
- Travel up to 20-30%
- Understanding of current Quality techniques, industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, quality, safety and efficacy of products
- Experience working with polymers, absorbable, implantable and/or chemical based processes or devices
- Strong familiarity with regulatory requirements (e.g., ISO 13485, ISO 14971, 21 CFR Part 11, 21 CFR 820, ISO 62304)
- Experience in risk evaluation techniques, such as PRA (Product Risk Assessment), FMEA & fault tree analysis
- Experience with 21CFR820, ISO13485, and ISO14971
- Proficient with utilization of quality tools (FMEA, Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, , FTA, DOE, etc.)
- Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 14971, ISO 13485 requirements
List of Typical Responsibilities For a Senior Design Quality Engineer Resume
1
Responsibilities For Senior Design Quality Engineer, Advanced Resume
- Develop and execute validation protocol
- Experience within the regulated environment of in vitro diagnostics or medical devices
- Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes
- Ensure compliance with internal and external procedures and regulations
- Participate in review of requirements, architecture, design, test results, code and other work products with a focus on patient safety and device quality, testability, manufacturability and serviceability
2
Responsibilities For Senior Design Quality Engineer New Product Development Resume
- Oversee defect resolution process
- Ensure that new product development and changes to existing products are conducted in compliance with the FDA Quality System Regulations and Covidien internal processes
- Oversee analysis of standards and product requirements compliance
- Assist, when appropriate with internal, agency, and supplier audits
- Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy
- Author and, or review/approve Quality Plan and Report at milestones DI, DO and LD. Assist management in assessment of whether project has met requirements to pass milestone
- Assist in the development of high level and departmental SOP’s governing or associated with design control
- Serve as primary quality representative on one or more project teams
- Manages all aspects of quality product management for commercially released products. This includes but is not limited to monitoring product field performance, addressing identified trends, technical and risk management based product analysis, leading consequent clinical impact to recommend any necessary corrective field actions
3
Responsibilities For Senior Design & Quality Engineer Resume
- Leads the Product Evaluation Committee (PEC) to investigate field reported events with a cross-functional audience. Presents overall field performance trends, clinical outcomes and device failures to the rest of the organization as input to improve product design or manufacturing processes
- Leads the initiation and executions of improvement plans across a variety of areas, using Lean principles, to increase efficiency, reduce cost and streamline operations. Participates in other sustaining engineering projects or initiatives
- Partners with cross-functional peers to resolve product performance issues (NCMRs, deviations, manufacturing process problems etc.) to ensure there is no negative impact on device quality and product availability. Participates in corrective/preventive action teams to resolve systemic issues
- Demonstrates excellent technical writing when authoring assigned Product Risk Assessment, Health Hazard Analyses, Post-Market Surveillance Reports. Facilitates Design FMEA and Risk Management File updates on assigned product lines
- Participate in all aspects of the creation and execution of functional/design requirements for new projects
- Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Manufacturing, Supply Chain, and Marketing
- Travel by air, rail, boat, and/or auto
- Direct exposure to health and safety hazards associated with production materials and equipment
4
Responsibilities For Senior Design Quality Engineer APV Resume
- Provide quality engineering support to evaluate, mitigate, re-certify and maintain compliance of the group’s products with the new EU Medical Device Regulation (MDR)
- Perform gap analysis of the group’s portfolio of products and technical files with respect the EU MDR
- Collaborate with cross functions within and outside the group to develop and execute mitigation projects
- Provide interpretations of regulations to the group
- Provide EU MDR compliance guidance
- Support re-certification of products
5
Responsibilities For Senior Design Quality Engineer Resume
- Your team orientation, strong communication skills and your assertiveness along with a high-quality awareness and an independent work style complete your profile
- Represents the QA function as a core team member on cross-functional teams supporting new product development
- Assesses overall product risk by facilitating the development of risk management tools such as fault tree analysis, failure mode and effects analyses (FMEAs), failure mode, effect and criticality analysis (FMECAs) and contributes to the completion of the overall product risk management file
- Monitors supplier performance and initiates corrective actions, as required
- Develops part qualification plans and supports the production part approval process
- Job requires interactions with project team members as well as members of the Quality extended team
- Provides support to other quality groups to assure efficient completion of project timelines
6
Responsibilities For Senior Design Quality Engineer, Advanced Resume
- Supports reliability activities for new product development. Drives for root cause understanding and corrective action implementation to ensure product meets reliability requirements
- Supports use of contract manufactures (CMs) and original equipment manufacturers (OEMs) including usage of appropriate supplier selection tools and creation of supplier quality management documentation
- Work related travel (Domestic and overseas) 10 – 25 %
- Strong working knowledge of QSR/cGMP, Design Controls, Systems/Software Development, Verification and Validation Principles and Practices, ISO 13485, EU IVD Directive, IEC 62304, Agile Development Methodologies
- Provision of quality leadership to new product development and sustaining project teams as the quality engineering representative. Work with the team to develop methods and procedures to ensure that the appropriate tests are conducted to meet the required design
- Actively participate in and/or facilitate the development, review and approval of requirements and deliverables to support medical device product software development
- Support Post market surveillance activities, Management review, Audits and inspections
- To perform all activities in compliance with relevant GMP, Smith & Nephew Quality Systems and safety standards and with FDA Quality System Regulation and ISO 13485
- + Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
7
Responsibilities For Senior Design Quality Engineer New Product Development Resume
- + Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
- Ensure conformity of the design process with applicable regulation
- Represent QA function within the core teams in charge of the development process
- Responsible for DHF completeness and maintenance
- Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics
- Generate and maintain the risk management files
- Review and Approve design and development documentation related to the products he/she’s in charge
8
Responsibilities For Senior Design & Quality Engineer Resume
- Fluent in English-written and verbal
- Experience in design verification and validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment
- Knowledge of EN62304, ISO14971, EN62366, EN61010
- Theoretical prediction of solder joint reliability with simulation
- Communicate (written, verbal) analyses results and proposed solutions with PM, Product Development, Test engineering, Process Engineering, Quality (manufacturing, customer, supplier etc.)
- Support new product development and design through design control activities
- Learn surgical procedures and map the product solutions into potential areas of risk and liability
- Conduct and lead process/design/procedural failure mode effects and analysis
- Conduct audits of new suppliers as part of the new product development project teams
9
Responsibilities For Senior Design Quality Engineer APV Resume
- Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Nonconforming Materials, Risk Management, etc
- Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements
- Experience with/Knowledge of: 21CFR820, ISO13485:2016, euMDD/ euMDR, ISO14971: 2007/ 2012 and medical device manufacturing
- Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, CFR 809 (IVDD), ISO 13485, etc
- Direct experience with FDA QSR and ISO 13485 compliance
- Knowledge and experience in application of statistics and lean sigma principles
- Experience or knowledge in reliability simulation in electronic products
- Experience in reliability simulations of electronic products (Sherlock)
10
Responsibilities For Senior Design Quality Engineer Resume
- Experience with new product development in the medical device industry
- Understanding of common software development approaches – Agile, etc
- Understanding of typical test strategies
- Working with these cross-functional groups, develop Project Quality Assurance Plan, and lead their implementation
- Based in a standard office setting but requires presence in surgical lab, operating room, laboratories, and supplier facilities
- Advanced degrees in a Science or Engineering field
- Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 1271, and any other specific product standard is an asset
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