Principal Quality Engineer Resume Sample

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Paul Hammes
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Work Experience


Principal Quality Engineer
09/2015 - PRESENT
Philadelphia, PA
  • Assist/lead new supplier qualification/assessment of finished goods, components, raw materials, and/or services
  • Monitor/manage existing contract manufacturers, private label & joint label suppliers to verify adherence to product requirements and ensure compliance with applicable FDA and International regulations
  • Responsible for reporting quality trends and information to management on the performance of sourcing-related quality suppliers, including escalation of any significant issues
  • Assist with design or product transfer and process validation (IQ, OQ, PQ) activities
  • Promote/lead/support supplier improvement initiatives to enhance product quality and supplier regulatory compliance
  • Effectively able to management tight deadlines with multi-suppliers and -tasks simultaneously
  • Support the development of policies, procedures, quality plans, and methods for the governance of sourcing management activities
  • Initiate/execute/direct corrective and preventive actions to problems/issues relating to process and/or product quality, such as complaint resolution, customer interface, and regulatory action
  • Assist the BU and Plant Management Representatives in preparation for third party audits (i.e. FDA inspections & notified body audits) and in the effective closure of findings resulting from such audits
Senior Principal Quality Engineer
09/2010 - 07/2015
Detroit, MI
  • Analyze stories, create manual and automated test cases that cover a broad range of client configurations
  • Provide feedback on user experience in order to ensure the best possible experience for our customers while promoting and implementing Continuous Integration and Delivery methodologies
  • Participate in the design reviews to understand design, contribute quality requirements and ensure testability
  • Work with development team to understand new product features for the purpose of designing and developing test cases
  • Troubleshoot issues discovered on test environments and by customers in order to identify potential root causes and reproducible steps
  • Review drawings and specifications as needed to insure control of product quality
  • Liaison to the manufacturing and assembly plants with manufacturing handoff of NPD/NPI products
  • Ensure that DFMEA actions are defined to appropriately mitigate project quality/reliability risks and drive completion of the identified actions within the project team
Senior / Principal Quality Engineer
09/2005 - 07/2010
Phoenix, AZ
  • Ensure that control plans exist and are capable of controlling function and quality at system, sub-assembly and component level as required. Ensure their delivery of quality at the suppliers and the earliest process step. Confirm effectiveness of the mistake proofed and control mechanisms
  • Lead the creation/capture of best practices and visibility/easy access via knowledge portal
  • Write, review and approve exceptions in the quality system
  • Review and approve OOS investigations in the quality system
  • Write, review and approve CAPAs in the quality system
  • Write, review and approve change controls in quality system
  • Review and approve customer complaints in quality system
  • Lead Quality continuous improvement efforts and projects

Education


Wittenberg University
2001 - 2005
Engineer's Degree in Engineering

Professional Skills


  • Strong analytical and problem solving skills and experience applying these skills to resolve quality problems in a manufacturing environment
  • Excellent communication skills (verbal and written) and problem solving skills required
  • Demonstrated ability to operate independently and prioritize product assurance requirements in light of competing priorities
  • Strong critical thinking/analytical skills with ability to solve complex problems using FMEA, DMAIC, 5 Why’s
  • Strong core technical coding skills: Java, Spring, Hibernate
  • Quality Engineering experience; 5+ years of Validation experience
  • Strong verbal, active listening, written communication skills

How to write Principal Quality Engineer Resume

Principal Quality Engineer role is responsible for analytical, leadership, engineering, technical, software, business, influencing, manufacturing, database, training.
To write great resume for principal quality engineer job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Principal Quality Engineer Resume

The section contact information is important in your principal 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
  • Email
  • Telephone number

Work Experience in Your Principal Quality Engineer Resume

The section work experience is an essential part of your principal 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 principal 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 principal quality engineer position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Principal Quality Engineer resume experience can include:

  • Excellent interpersonal relationship skills including influencing and relationship management skills
  • Demonstrated ability to lead and work effectively in a team environment, and drive effective cross-functional results
  • + Effective influencing skills, including building rapport with internal customers.
  • Engineering tools utilization experience such as design of experiments, risk management, validation, methodical problem solving and statistical analysis
  • Prior experience with leading and integrating acquired sites into the quality system and performing remediation
  • Software test automation experience using Java/J2EE with a proven track record of working on technically demanding projects

Education on a Principal Quality Engineer Resume

Make sure to make education a priority on your principal 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 principal 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 Principal Quality Engineer Resume

When listing skills on your principal 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 principal quality engineer skills:

  • Interface effectively across departments and build strong and cooperative working relationships
  • Demonstrate planning and leadership skills, as well as attention to detail
  • Analytical skills and experience leading risk-based oversight programs
  • Good debugging, troubleshooting, and analytical skills
  • Excellent planning, organization and time management skills are required
  • Demonstrated root cause and problem-solving skills are necessary

List of Typical Experience For a Principal Quality Engineer Resume

1

Experience For Senior Principal Quality Engineer Resume

  • Demonstrates excellent knowledge of statistical sampling and analysis tools/methods
  • Effectively deal and negotiate with members of BD multi-functional Business Units and representatives of various government and regulatory agencies
  • Able to effectively liaise with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and visitors
  • Experience in Quality, Manufacturing, Engineering or related field
  • Experience in driving improvement and implementing change
  • Strong working knowledge of ISO, Medical Device Directive, GMP/QSR and other applicable regulations
  • Strong strategic decision-making ability related to regional or business line Quality policies and programs
  • Experience with Red Hat Enterprise Linux (RHEL) or UNIX operating systems
  • Experience in a pharmaceutical manufacturing environment, knowledge of GMP regulations and guidelines
2

Experience For Principal Quality Engineer NPD Heart Valve Therapy Resume

  • Strong focus on continual improvement and reporting on process and product performance/ process capability studies
  • Experience documenting security plans, procedures, policies, standards, risk assessments and ST&Es required
  • Relevant experience
  • Reviewed RFQ’s and PO’s prior to issue to vendor to ensure all quality requirements have been included in the package
  • Analyze and prioritize the quality risks posed by Red Hat JBoss solutions and determine the tests required to mitigate these risks
  • Previous experience with Ant, Maven, Gradle, SVN, Git
  • Industry experience in QA or software development
  • Experience with open source tools like Cucumber, Selenium, and JMeter
  • Experience with REST API, Java and Javascript
3

Experience For Senior / Principal Quality Engineer Resume

  • The analyst solves business problems and, as needed, designs technical solutions to ensure an efficient, effective and compliant Quality System
  • Analyze and prioritize the quality risks and determine the tests required to mitigate them
  • Commercial experience with JEE and related technology
  • Experience with Red Hat JBoss Middleware and other middleware offerings
  • Provides project quality leadership for validation or SLC activities
  • Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
  • Practical experience with Java SE and JEE
4

Experience For Principal Quality Engineer Asme Control Resume

  • + Good understanding of medical device product development processes.
  • + At least 3 years’ experience within the medical device industry.
  • + Self-starter and accountable, with sharp focus on quality and customer experience.
  • + Excellent verbal and written communication
  • Experience in 21CFR820, ISO13485, ISO 14971, CMDR and Medical Device Directive
  • Leverage processes and tools across Deliver/BQ through strong collaboration with the business to accelerate value
  • Proven ability to influence others and lead significant change
  • Previous experience with Root Cause Analysis and Statistical Techniques
5

Experience For Products Software Principal Quality Engineer Resume

  • Gathering, analyzing, and communicating test results to project team and management
  • Coordinating execution of integration, functional and end to end testing
  • Standing member of multiple controlled environment standards (e.g. ISO/ AAMI/ IEST/ ISPE) working groups
  • Building consensus and impacting outcome with limited authority and ability to negotiate trade off decisions across the organization and take decisive action
  • Working knowledge of a modern programming language
  • Working knowledge of applicable standards and regulations standards (including, but not limited to: ISO13485, MDD and 21 CFR 820)
  • Understanding of the principles of continuous integration (CI)
6

Experience For Principal, Quality Engineer, Audience Studio Resume

  • Understanding of basic statistical principles, expert knowledge of regulatory affair principles, techniques, and regulatory expectations
  • Understanding and use of APIs in large-scale distributed systems
  • Working competency of statistical programs (i.e., Minitab, SAS, etc.)
  • Drive continuous improvement of related quality system processes and tools, including but not limited to updating procedures and deploying training
  • Actively participating in but not limited to Test Case Review, Scrum, Stand-up, Grooming and Retrospective meetings
7

Experience For Principal Quality Engineer Resume

  • Actively drive developing test strategy, test planning, and product delivery decision
  • Actively participate in defining testing strategies for Red Hat JBoss Enterprise Application Platform
  • High troubleshooting and problem analysis/solving abilities
  • Correlate process data with manufacturing and engineering information
  • Liaison with purchasing, R&D and marketing on product specific initiatives
8

Experience For Senior Principal Quality Engineer Resume

  • Manage projects involving multiple functional groups without direct reporting authority
  • BS in Engineering - preferably software, mechanical, or electrical engineering
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal polices to assure compliance
  • Develop and maintain compliance policies supporting the ventilation quality system
  • Assists with facilitating external audits and with audit readiness preparation
  • Acts as deputy to the site Quality Manager during absence from facility
  • Evaluate, review, and approve Quality System records related to nonconforming events or corrective actions
  • Develop Master quality test plan, including V&V & Reliability
  • Ensure that control plans exist and are capable of controlling function and quality at system, sub-assembly and component level as required
9

Experience For Principal Quality Engineer NPD Heart Valve Therapy Resume

  • Review and approve vendor documentation including inter alia Inspection & Test Plans,
  • Coordinate third party inspection to cover quality surveillance and monitoring of supply chain and management of discipline inspectors
  • Analyzes production quality issues and manages the identification, documentation, segregation and disposition of any potentially non-conforming product
  • Coordinates with customer facilities and internal engineering resources to respond to customer facility questions and resolve complaints
  • Provides training as needed to ensure assemblers understand and follow applicable requirements
  • Communicates significant issues or developments identified during quality activities and lead process improvements to instill rigor in process and product
  • Support cross functional teams in conducting risk management activities
  • Author and design new framework to incorporate all the existing tools and process
10

Experience For Senior / Principal Quality Engineer Resume

  • Play an important role in defining the certification plan for builds and final product
  • Expand test coverage through automation using open source or commercial tools
  • Design and develop test automation frameworks for various environments like clouds, multiple operating systems, large clusters, containers, etc
  • Participate in all lifecycle phases for product development including design, implementation, and delivery
  • Act as an expert and influencer within the team for testing tools and best practices
  • Knowledge of open source development tools and testing and automation tools
  • Designs and performs development working independently within defined parameters with minimal supervision required

List of Typical Skills For a Principal Quality Engineer Resume

1

Skills For Senior Principal Quality Engineer Resume

  • Strong project management skills, including coordinating large cross functional teams and presenting to senior management
  • Strong analytical, technical writing, verbal communication and interpersonal skills
  • Strong analytical and problem-solving skills, self-motivated, creative and detail oriented
  • Strong core database skills, especially with SQL
  • Demonstrate problem solving skills pertaining to working knowledge of Corrective Action and Preventive Actions (CAPA)
  • Excellent leadership skills, ability to identify and hire talent to support the business needs
  • Good communication and presentation skills, especially with higher management on business-critical initiatives
  • Strong managerial skills and ability to manage multiple departmental budgets required
  • Demonstrates leadership skills and ability to work independently
2

Skills For Principal Quality Engineer NPD Heart Valve Therapy Resume

  • Thorough knowledge of quality systems, validation principles for product and manufacturing processes, and strong engineering design fundamentals
  • Able to demonstrate inspection experience (NDE, welding, coating, pressure vessel, etc.)
  • Provide necessary training and mentoring on analytical skills i.e. Lean, Six Sigma, FPX etc
  • Advanced engineering/scientific skills/specialized technical expertise
  • BS in engineering or Science Field with 9-13 years of relevant experience OR MS with 7-11 years of relevant experience
  • Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards GxP requirements and regulations
3

Skills For Senior / Principal Quality Engineer Resume

  • Experience with a proven track record of implementing appropriate risk mitigation w/in-depth knowledge of product/process Risk Management (FDA & ISO standards)
  • Quality experience or experience working in a regulated industry
  • Computer skills including office software such as Microsoft Office (Word, Excel, PowerPoint, MS Project) and SAP
  • Create and apply risk-based approach strategies effectively and efficiently without compromising compliance
  • Multi-tasking skills and the ability to work under tight deadlines
  • Organizational communication and coordination experience along with multi-tasking experience
  • Determines or effectively recommends course of action after considering potential risks of alternatives
4

Skills For Principal Quality Engineer Asme Control Resume

  • Deliver proven practices to improve process, product, and service quality in alignment with business goals and priorities
  • Related work experience, or demonstrated performance
  • Work effectively in a team environment with a diverse group of people
  • Computer experience is required; experience with a computer based production control system desired
  • Expertise with Test Method Validation, Process Validation (IQ/OQ/PQ
  • Work with minimal guidance when necessary, and manage own time effectively
  • Compose test plan based on project process, business objectives, resources and required technologies & skills
  • Work closely with customer support and development teams to drive root cause analysis and feed that knowledge into automated quality processes effectively
5

Skills For Products Software Principal Quality Engineer Resume

  • Interpersonal Skills and Communication Proficiency
  • Collaborate with other functional areas to ensure TMV validation approach is effective across the Neuromodulation organization
  • Represent the test method validation discipline as a member of the Validation Governance Board
  • Use influence and collaboration skills with functional partners to accomplish objectives
  • Working experience with automated testing tools
  • Understanding of new product introduction processes, and expertise in process qualifications/ validations
  • Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive
  • Using tools such as Design of Experiments (DOE) and statistical evaluations of data, develop a strong portfolio of knowledge for product risk evaluations
6

Skills For Principal, Quality Engineer, Audience Studio Resume

  • Experience in Test Engineering, Manufacturing Engineering, or Design Engineering highly desired
  • Experience generating, reviewing and / or implementing policies and procedures
  • Project management experience, including scoping, planning, execution and resource management
  • Work experience in any of the following R&D / Source / Manufacturing / Engineering / Quality / Delivery or equivalent is required
  • Accountable for identifying and implementing GMP (Good Manufacturing practices) that apply to a specific product area
  • Experience designing, implementing, and executing automated tests
7

Skills For Principal Quality Engineer Resume

  • Effective and efficient Problem Solving using the Danaher Problem Solving Process
  • Very high technical abilities and experience, including scripting/code writing
  • Experience with leading automation efforts and writing and debugging automation tests for complex enterprise software
  • Engineering experience in Quality, Engineering, Operations
  • Experience defining and executing complex system tests
  • Experience in Quality, Manufacturing, Engineering or related field
8

Skills For Senior Principal Quality Engineer Resume

  • Demonstrated success owning and achieving metric improvement goals through cross-functional project management, required
  • Experience in a medical device manufacturing environment in an engineering or QA role
  • Good understanding of post market vigilance and complaint handling practices
  • Good understanding of field corrective actions, including recalls, field actions, field safety corrective actions, and safety notices
  • Experience testing Spring Framework-based apps
9

Skills For Principal Quality Engineer NPD Heart Valve Therapy Resume

  • Combined experience in Quality/Regulatory, Manufacturing, Design, Continuous Improvement, Sourcing, Laboratory and/or equivalent functions
  • Applicants are encouraged to provide writing samples that demonstrate their capabilities in creating design control documentation
  • Experience in driving Design for Manufacturing (DFM) and Design for Reliability (DFR) in a stage-gate NPI process
  • Experience with troubleshooting and debugging in Linux and UNIX environments
  • Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition
  • Highly functioning team leader and team member in a multi-skilled, dynamic business environment
10

Skills For Senior / Principal Quality Engineer Resume

  • Account and approve time in time management system. Manage CAPAL processes ensuring problem identification and effective resolution
  • Experience building platforms from scratch
  • Prior interactions with the following disciplines: CAPA, risk management, post market complaints
  • Quality, Engineering or Operations experience in the pharmaceutical and/or medical device industry
  • Experience within Operations in a manufacturing organization with a metric and results driven culture, required
  • Hands on experience using Lean and Six Sigma methodologies
  • Knowledge or experience working with Single Use Device (SUD) BSC or other Medical device manufacturer products
  • Demonstrable Management experience and ability to provide direction, development and management of departmental budget; training needs preparation etc

List of Typical Responsibilities For a Principal Quality Engineer Resume

1

Responsibilities For Senior Principal Quality Engineer Resume

  • Demonstrates excellent organizational, verbal and written communication skills
  • Solid background and skills with Linux
  • Inter-personal skills and demonstrated ability to teach lay staff quality principles
  • Excellent oral and written communication skills to report to senior leadership
  • Prior experience in the Medical Device industry in design and development of Medical Devices and Test Method Validation
  • Manufacturing process validation experience required
  • Experience, with at least 4+ years’ experience in drug manufacturing and cGMP
  • Collaborate and communicate effectively with a global team
  • Demonstrates excellent knowledge of risk management per ISO 14971
2

Responsibilities For Principal Quality Engineer NPD Heart Valve Therapy Resume

  • Apply analytical skills as issues arise within the department and Plant-wide to initiate proper corrective action
  • Experience managing projects, and demonstrating project leadership abilities required.
  • Strong knowledge and application of statistical analysis to support data-driven decision making
  • Experience in Quality Engineering
  • Experience with cross-functional teams, including technical/non-technical work
  • Responsible for acting as department technical expert in change reviews, verifications and validations
  • + Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive
3

Responsibilities For Senior / Principal Quality Engineer Resume

  • + Previous experience working in a cross-functional team environment
  • Software industry experience and successful track record in product testing
  • Experience on any performance testing tool (HP Loadrunner, Jmeter, etc.)
  • At least five years’ experience within Operations in a manufacturing organization with a metric and results driven culture, required
4

Responsibilities For Principal Quality Engineer Asme Control Resume

  • Strong operating knowledge of Word, Excel, and PowerPoint computer applications
  • Semiconductor process, PWA, microcircuit manufacturing experience highly desirable
  • Product Qualification and Acceptance testing experience
  • Product Engineering with experience in transition to production
  • At least eight years’ experience within Operations in a manufacturing organization with a metric and results driven culture, required
5

Responsibilities For Products Software Principal Quality Engineer Resume

  • Experience with APQP and related tools, including FMEA, Control Plans and PPAP’s
  • Experience working as a Quality Engineer
  • Experience conducting data analysis with Excel, Minitab, or other similar programs
  • Good understanding of clinical aspects as related to Class III medical devices
  • Experience with risk management process (ISO 14971), including risk assessment tools & methodologies
  • Experience with service contract testing: microservices, JUnit, Mockito, etc
  • Experience with testing frameworks: Selenium, RSpec, etc
  • Experience with billing or financial applications
  • Experience testing multi-tiered SaaS applications
6

Responsibilities For Principal, Quality Engineer, Audience Studio Resume

  • Experience in a Quality role in a manufacturing environment
  • Experience in Semiconductors/Integrated Circuits Manufacturing & Test
  • Proven ability to solve problems, analyze data using statistical concepts and tools
  • Experience in Usability/Human Factors Engineering desired
  • Project Management experiences or training on Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.)
  • Knowledge and experience in ASME, API, AWS, AS, BS, DNV, TEMA, NORSOK, ISO, ASNT, ASTM, NACE, SSPC, AISC and EN standards
7

Responsibilities For Principal Quality Engineer Resume

  • Develop, review and approve validations and completion reports for new and existing products, processes nd equipment
  • Demonstrated aptitude of change management and sustainment, required
  • Experience in the medical device, pharmaceutical or other highly regulated field is required
  • Provide guidance and direction for identification of sample size and statistical analysis of verification and validation test protocols and results
  • Experience in a Quality or Compliance role in medical device industry
  • Experience with Protractor, Rspec and/or Selenium
  • Experience in Javascript, Java and/or Ruby/Rails
8

Responsibilities For Senior Principal Quality Engineer Resume

  • Good knowledge of test automation using frameworks
  • Experience writing clear, concise, and comprehensive test plans and test cases
  • Experience with continuous integration (CI) and automation frameworks
  • Supervise Lab technicians in the inspection, evaluation, and analysis of end product, work in-process, and returned goods
  • Identify and execute changes to TMV procedures and training to improve efficiency, effectiveness, and sustainability
  • Demonstrated success in managing multiple projects is required
  • Strong technical knowledge applicable to photonics, optics, opto-mechanical and electro-optical, lasers and motion/vibration control Quality requirements
  • Experience with root cause analysis tools and gap identification
9

Responsibilities For Principal Quality Engineer NPD Heart Valve Therapy Resume

  • Experience with test and CI frameworks like Karma, jUnit, TestNG and Bambo or Jenkins
  • Experience with cloud platforms such as AWS, Azure and Hadoop
  • 1+ Project Management and strong cross-functional business acumen
  • Experience with cloud-based applications highly desired
  • High personal integrity with a positive attitude and a strong work ethic
  • Able to prioritize projects and manage assigned Quality resources to meet organizational goals and objectives
10

Responsibilities For Senior / Principal Quality Engineer Resume

  • Professional experience in the commercial nuclear power industry or similarly regulated industry environment is required
  • Experience with digital instrumentation & control systems, electrical panels, and electro-mechanical devices
  • Significant Quality/project experience
  • Experience in Medical Devices, Biologics or Pharmaceuticals is also required
  • Intermediate to advanced knowledge in Statistics, Design Control, Risk Assessment and Process Validation is required

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