Quality Assurance Director Resume Sample

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Valentina Krajcik
4582 Zena Inlet,  Los Angeles,  CA
+1 (555) 110 6575

Work Experience


Director of Quality Assurance
12/2017 - PRESENT
Boston, MA
  • Create and execute processes to monitor TOMS’ production quality. Early detection of quality issues is a priority of these processes
  • Support TOMS product development, especially with regards to product launches and product upgrades—create and implement test procedures to mitigate risk of product failure and maintain TOMS’ high quality and fit/comfort standards
  • Manage TOMS’ fit and wear testing programs
  • Develop and maintain the Quality System Manual in compliance with requirements of FDA and internal QA index (GMP’s) requirements/guidelines
  • Takes an active role in qualification of OPI’s contracted manufacturers
  • Maintains a clear understanding and working knowledge of GMP requirements, Safety requirements, and SOP’s
  • Drives cultural shifts across businesses and stakeholder groups to create readiness for change and influence behavior
  • Incorporates a common vision and a future view that sets direction and influences change through others
Quality Assurance Director
02/2013 - 09/2017
Houston, TX
  • Establishes networks across the company to influence the design phase of change across extensive business areas
  • Is sought out for his or her opinions and advice on business decisions and change
  • In close collaboration with the LOB technology team and the QMS COE QA and the strategic partners, ensures the testing technology stack available for each test team is the most effective and efficient for the architecture and design deployed with that LOB’s products, projects, work packages and M&PS efforts
  • Determines and creates policies, procedures and manuals for direct reports
  • Establishes objectives and goals for the team; plans, organizes and manages work flow
  • Assigns, monitors, and reviews work; evaluates direct report’s performance
  • Recruit, interview, train, discipline, and terminate direct reports
  • Orientate and train direct reports
  • Approves time records and time off requests; submits payroll for direct reports
Director Business Analysis & Quality Assurance
01/2010 - 11/2012
Phoenix, AZ
  • Investigates and resolves concerns and complaints
  • Provide assistance and support; maintains a positive and professional working environment
  • Inspire a culture of quality across the organization
  • Act as the ombudsman for customers, ensuring the company addresses their requirements and concerns in a professional and timely manner
  • Provide visibility to the management with corrective actions through regular reports on all matters pertaining to quality issues and standards
  • Create professional working relationships with corporate and local management, customers, and vendors
  • Develop and manage a Quality Assurance team, including budgeting, training, performance reviews, guidance, and coaching
  • Define quality procedures and metrics to support and enhance manufacturing quality

Education


Globe University / Minnesota School of Business
2006 - 2010
Bachelor's Degree in Accounting

Professional Skills


  • Excellent verbal and written communication skills and effective presentation skills to a wide range of audiences including internal and external stakeholders
  • Demonstrated leadership, coaching, goal setting, and mentoring skills driving the performance of QA teams across multiple geographies
  • Attention to detail with excellent analytical and problem-solving skills
  • Experience within the Medical Device industry with proven experience in Quality System Management following Worldwide Regulations and Standards
  • Strong skills in critical thinking, analysis, project management and organization
  • Strong computer skills including quality control applications, word processing, spreadsheets and databases
  • Excellent community development & project management skills and thorough understanding of LEAP, the Development Program Approach and M&E Partnership frameworks

How to write Quality Assurance Director Resume

Quality Assurance Director role is responsible for leadership, interpersonal, software, building, presentation, analytical, design, training, planning, manufacturing.
To write great resume for quality assurance director job, your resume must include:

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

Contact Information For Quality Assurance Director Resume

The section contact information is important in your quality assurance director 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 Quality Assurance Director Resume

The section work experience is an essential part of your quality assurance director 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 quality assurance director responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality assurance director position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Quality Assurance Director resume experience can include:

  • Demonstrated skills in building and motivating teams
  • Strong experience with Quality Center, automated testing, agile/waterfall SDLC, and project testing leadership
  • Quality assurance and food safety experience with at least 10 years of experience managing others required
  • Exceptional verbal, written, listening and presentation communication skills required
  • Strong team building ability and experience
  • Experience in Quality Assurance with demonstrated increasing expertise and responsibility in the biotech or pharmaceutical industry

Education on a Quality Assurance Director Resume

Make sure to make education a priority on your quality assurance director resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality assurance director 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 Quality Assurance Director Resume

When listing skills on your quality assurance director 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 quality assurance director skills:

  • Good team player, able to take initiative, good planning and organizational skills, dedicated to excellence/success
  • Build a strong team with good spirit, knowledge and skills. Develop succession planning to support future business needs
  • Experience managing larger offshore teams and managing numerous projects effectively simultaneously
  • Excellent organizational, managerial and communication skills
  • Writing skills to present technical and management documents in a clear and concise manner encompassing company standards
  • Prior experience writing/editing SOPs, training people, issuing/ performing CAPAs, performing/overseeing improvements

List of Typical Experience For a Quality Assurance Director Resume

1

Experience For Director of Quality Assurance Resume

  • Strong work ethic with excellent interpersonal skills and the ability to develop effective business relationships
  • Strong organization, communication and teamwork skills to be able to effectively interact within multidisciplinary
  • Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges
  • Proven leadership experience in developing and managing Data Quality, Data Warehouse and reporting QA organizations
  • Strong familiarity and experience in latest technologies handling multi-TB sized data systems – both structured and unstructured formats
  • Progressive managerial experience within the Quality function of a pharmaceutical company. Experience leading a Quality function is required
  • Demonstrated experience influencing a company’s development strategies and product delivery processes
  • Demonstrated experience managing within both Agile and Waterfall SLDCs
  • Ensure root cause analysis and corrective action activities are rapidly and effectively implemented
2

Experience For Senior Director of Quality Assurance Resume

  • Cooperate with other division heads to assure an effective, profitable company operations
  • Communicate effectively with subordinates and upper levels of leadership
  • Understanding and practical experience in Design Control requirements
  • Understanding and practical experience in Risk Assessment as applied to Medical Devices (e.g., FMEA, FTA, Hazard Analysis, etc.)
  • Keeping the management staff informed of the status, adequacy, and overall effectiveness of the quality management system
  • Strong understanding of current and emerging technologies in data, open source software, machine learning and cloud computing
  • Experienced engineering executive, well versed in building outstanding organizations
3

Experience For Director Business Analysis & Quality Assurance Resume

  • Experienced Project Leader with sound training methods, sharing knowledge, and facilitating
  • Demonstrated success defining and implementing software quality standards, methodologies and metrics to meet business goals
  • Work with members of the team to ensure process compliance, effectiveness, and focus on continual improvement, while maintaining focus on customer satisfaction
  • Perform root-cause analysis and other problem solving activities to identify effective corrective action and process improvements
  • Skilled at quality assurance principles, food science and flavors/spice processing, SPC and statistics
  • Good working knowledge of Statistical techniques: basic statistics, Statistical Process Control, Design of Experiments
  • Experience with manufacturing large volumes of sterile single use devices
4

Experience For Director, Clinical Quality Assurance Resume

  • Experience with Quality Management Systems (e.g. documentation and records management, change control, deviations, investigations, training, and CAPA programs)
  • Experience in the use of relevant computer systems used in clinical and non-clinical research including safety databases
  • Collaborate with Program Director and Nurse Manager for continuity of supervision and training experiences
  • Hands-on experience in handling software QA or data quality responsibilities at enterprise level
  • Hands on experience and proficiency in ETL, SQL + Scripting, Big Data and analytic technologies
  • Experience in delivering services in a fast-paced agile environment
  • In experience managing a team
  • Proven track-record of leadership & building relationships with both internal & external customers
  • Validate the existing QA process framework and adjust as necessary to meet the objectives of quality management
5

Experience For Director, Global Design Quality Assurance Resume

  • Possess a leadership style that is effective at influencing organizational cultural change
  • Know and live the Sunrise Mission, Principles of Service and Core Values; demonstrate serving leadership and act as a role model
  • Experience with the planning, implementation, and use of automation tools and test suites in the delivery products
  • Communication, Effective creative methods of cascading key message
  • Eight years of experience in managing QE/QA programs in the medical device and/or pharmaceutical industry
  • Monitor and review appropriate KPIs (such as yields and RMAs), facilitate relevant meetings, and drive focus on quality improvement through prioritization
  • In collaboration with Supply Chain, plan, develop, and implement effective supplier selection and management processes
  • Experience in transformation and change management
6

Experience For Program Effectiveness & Quality Assurance Technical Director Resume

  • Quality Management experience in a related field
  • Analyze customers’ product specifications to establish efficient, cost-effective requirements for ease of manufacture and responsibility
  • Comprehensive experience with FDA Rules and Regulations
  • Experience with food safety regulations in the USA
  • Good understand of Quality System regulations and requirements and ability to assess and implement quality assurance system
  • Demonstrate flexibility and manage multiple complex projects simultaneously
7

Experience For Director, Post-marketing Quality Assurance Resume

  • Recruiting, hiring, training staff, evaluating employee performance, and recommending or initiating promotions, transfers, and disciplinary action
  • Monitoring and advising on the performance of the total quality management system, producing data and reporting on performance through KPI's
  • Making sure that manufacturing or production processes meet GFSI Global Food Safety Initiative Standards
  • Ensuring the execution of corrective actions and ongoing compliance with customers' specifications
  • Managing corporate quality systems including TraceGains and other quality platforms
8

Experience For Global Quality Assurance Director Resume

  • Defining the quality plan, including an internal and external quality audit plan, seek approval for it and implement and manage the execution of this plan
  • Auditing and testing systems for in-process and finished products to ensure conformance to internal, customer, and regulatory requirements
  • Working knowledge of nuclear plant design, and engineering requirements, fabrication and related quality activities
  • Partnering with other business departments to ensure the procurement of materials that meet our specifications
  • Reviewing statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality assurance
  • Working knowledge of general work place safety
9

Experience For Corporate Quality Assurance Director Resume

  • Ensuring that DRF achieves and maintains appropriate levels of quality compliance (cGMP, ISO)
  • Monitoring the execution of the quality plan and take corrective actions, in order to achieve the results
  • Challenging Sites, Change Management
  • Establishing Community of Practice
  • Managing the “Grey Space” application & interpretation
  • Lead the development, ongoing refinement, monitoring, tracking and reporting of WV DRC’s Strategy including Technical Programs
10

Experience For Regional Director of Quality Assurance Resume

  • Leads investigating and implementing corrective/preventative action for customer complaints, nonconforming products, and nonconforming systems
  • Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer
  • Assist in maintaining the Compliance Monitoring Inventory (e.g., enter new activities, change in staffing) and Scenario Master
  • Assist with coordinating with leaders in all relevant departments in maintaining and expanding Quality Assurance’s role as needed
  • Setup and maintain record controls, documentation, CAPA and internal audit procedures, including associated meetings and reporting
  • Monitor performance by gathering relevant data and producing statistical reports with corrective action oversight for changes and improvements

List of Typical Skills For a Quality Assurance Director Resume

1

Skills For Director of Quality Assurance Resume

  • Excellent motivational and cross-functional team building skills
  • A high level of human relations skills in selecting, developing, and motivating people
  • Strong PV knowledge, including experience working in alliance partnerships
  • Prior experience managing and leading multiple departments and professional technical employees
  • Prior experience conducting/ participating in audits
  • Proven leadership experience leading teams supporting Oncology clinical studies
  • Team building skills to promote quality achievement, maximize effort and foster an environment of performance improvement amongst all team members
  • Strong leadership and demonstrated success in managing a team
2

Skills For Senior Director of Quality Assurance Resume

  • Well versed in statistics, analytical reasoning skills based on data
  • Drug Safety experience; 5+ years of experience in Quality Assurance
  • Well versed in English language skills, both verbal and written
  • Experience in working with International NGOs with relevant community development with at least 3 years direct program management experience
  • Solid engineering foundation indicated by a demonstrated understanding of product design, life cycle, software development practices, and support services
  • Significant prior experience in GLP QA
  • Collaborates effectively with the PMO Director and Portfolio Manager
  • Effectively manages the expectations of project members, project stakeholders, and customers
3

Skills For Director Business Analysis & Quality Assurance Resume

  • Strong analytical mind in defining problems, gathering data and designing solutions to resolve problems
  • Extensive experience using enterprise-level quality reporting and quality tracking systems
  • At least two years’ experience analyzing performance metrics & conducting trend analysis
  • Places a priority on getting results with an emphasis on high quality outcomes
  • Experience with resource planning and governance and the establishment of Quality Center of Excellence
  • Experience managing web based test automation development
4

Skills For Director, Clinical Quality Assurance Resume

  • Strong understanding of WV’s field operations
  • Experience working in an agile development cycle
  • Deep experience using metrics and trends to measure and monitor quality outcomes
  • Clinical research management experience in an academic setting, pharmaceutical company environment or in a regulatory agency
  • Previous working knowledge and experience with the FDA and Pharmaceutical sponsors
  • Strong knowledge of software/system testing metrics, best practices, and methodologies (manual and automated)
  • Excellent knowledge of European and US regulatory standards (RoHS, REACH, FDA, CPSC, etc) and testing/certification standards
  • Experience managing projects and/or staff
  • Experience managing B2C software quality initiatives on mobile devices, both native and responsive
5

Skills For Director, Global Design Quality Assurance Resume

  • Excellent knowledge of management methods and specifications, including design control processes
  • Demonstrated ability to work on a global cross-functional project teams or within a global quality team
  • Maintain excellent working relationship with all team members, peers, partners and all others within and outside Analytics & Data organization
  • Excellent knowledge of ICH, US & EU regulations and requirements for Pharmacovigilance
  • Experience with the delivery of hardware products in addition to software is a benefit
  • Experience with international software and international hardware compliance and regulatory requirements helpful
  • Related quality experience in an ISO 13485 and cGMP in an FDA regulated environment. (Preferably med device)
  • Extensive knowledge of FDA current Good Manufacturing Practices and the Code of Federal Regulations as applicable for dietary supplements
  • Engage with governmental, NGO and other senior leaders on issues of justice, child rights and development and maintain effective partnerships
6

Skills For Program Effectiveness & Quality Assurance Technical Director Resume

  • Partners and builds strong relationships and able to influence outcomes
  • Design and produce quality summary reports (using Jira and EazyBI) for each project that demonstrate the health of a project from a code quality perspective
  • Experience as a leader in the software quality and process improvement space in an e-commerce B2C business
  • Standardizing operational control programs including food safety plans, FSMA, corporate quality and pressure testing at all plants
  • Providing guidance and oversight as necessary to managers regarding manager’s responsibility to
  • Maintaining best quality and measurement standard by establishing new standards for new categories/styles and revisit the current standards when necessary
7

Skills For Director, Post-marketing Quality Assurance Resume

  • Developing and ensuring quality policies and procedures are appropriately maintained, recorded and administered
  • Evaluating quality risk assessments and assisting plants in reduction of non-conformances
  • Ensuring personnel are trained in appropriate aspects of quality systems and programs to ensure compliance with establish quality process/procedures
  • Working knowledge of relevant IT systems
  • Mentoring test team members, develop and critique test plans and test cases
  • Establishes in-process product inspection standards by studying manufacturing methods; devising testing methods and procedures
  • Demonstrable leadership and team evangelizing abilities in changing, ambiguous and challenging situations
8

Skills For Global Quality Assurance Director Resume

  • Exposure to test reporting knowledge and review, using TestNG, SoapUI and QTP reporting
  • Knowledge of laboratory testing procedures including chemical, microbiology, and basic instrument testing, as well as sensory analysis
  • Responsible for managing all Quality Initiatives – training, testing, data quality
  • Three or more years’ experience developing and implementing a Testing Strategy and Test Plan for large scale development projects, preferably in a healthcare environment
  • Experience working across geographies and managing global projects
  • Extensive knowledge of FDA regulations relevant to drugs, devices, biologics. Previous experience hosting and responding to FDA inspections
9

Skills For Corporate Quality Assurance Director Resume

  • Experience in developing automated testing framework
  • Experience in leading and delivering multiple concurrently multi-million dollar projects annually
  • Internal quality auditing training or experience
  • Anticipates future needs within the function when selecting and developing talent (e.g., develops successors and talent pools for key positions)
  • Create key quality metrics for tracking and trending data related to GCP activities, report metrics and significant quality incidents to QA management
  • Knowledge of QATesting tools, and the ability to integrate testing tools into a CI/CD pipeline
  • Recruits, motivates and develops a high performing RQA team with a focus on commitment to achieving high quality deliverables with a culture of collaboration
10

Skills For Regional Director of Quality Assurance Resume

  • BS in Science related field, including engineering
  • Assist in major project planning and train personnel in the quality planning procedures
  • Champions new ideas and approaches, moving them forward into action
  • Directs and manages subordinates to complete assignments using established guidelines, procedures and polices
  • Conduct and coordinate GCP compliance training to internal and external customers (as required)

List of Typical Responsibilities For a Quality Assurance Director Resume

1

Responsibilities For Director of Quality Assurance Resume

  • Assume responsibility for QA reviews of various functions performed by AML Compliance such as reviewing clearance of surveillance items flagged as potentially suspicious transactions
  • Excellent communications skills, both written and verbal. Strong interpersonal skills
  • A thorough working knowledge of regulatory compliance, process validation, technology transfer, plant engineering and competent PC skills
  • Demonstrate strong leadership by providing an objective, high energy, consistent work ethic and aligning teams to a common vision and goals
  • Promote cGMP compliance through training and monitoring SOP effectively
  • Communication skills-oral/written, math computations, organized, Microsoft Office, Statistical sampling techniques/ statistical writing
  • Coordinate/communicate effectively with other OCDI Jr. clinicians providing supervision to practicum students
2

Responsibilities For Senior Director of Quality Assurance Resume

  • Manage internal and external clients' expectations related to quality management, and effectively communicate corporate quality standards across the project
  • Demonstrate experience with setting up QA practice for new system build
  • Scheduling and approving supplier audits and surveys prior to placement on the authorized suppliers’ list
  • Previous experience in building and leading Quality Assurance group within the framework of outsourcing model
  • Experience building, managing and motivating high-performance teams with a focus on continuous improvement and customer service
  • Experience in bringing products from clinical to commercial and understanding appropriate GMP requirements
  • Strong understanding of manufacturing processes used in the manufacture of small molecules
  • Experience in planning and conducting GCP and GLP audits
  • Experience reviewing and auditing study-related documentation (e.g. study reports, Investigator Brochures)
3

Responsibilities For Director Business Analysis & Quality Assurance Resume

  • Experience with creating quality systems in fast paced working environment
  • Experience building QA strategies, process improvement, metrics development, and manufacturing practices
  • Experience leading and managing on-site and off-shore geographically distributed teams
  • Extensive experience participating in and managing B2C software quality initiatives on mobile devices, both native and responsive
  • Experience running a software application performance testing function, within or outside of a QA group
  • Strong Knowledge of FDA government regulatory requirements pertaining to manufacturing of nutritional supplement and/or pharmaceutical products
  • Influence and build strong working relationships across organizations and geographies
4

Responsibilities For Director, Clinical Quality Assurance Resume

  • QA Experience with 5+ Managing Employees
  • Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines
  • Experience in developing SOPs in for quality assurance and compliance
  • Knowledge and significant experience with structured risk-based testing
  • Strong Knowledge of test management and issues tracking systems
5

Responsibilities For Director, Global Design Quality Assurance Resume

  • Manage a skilled QA team tasked with expanding the test coverage for all test efforts, particularly in mobile, data integrity, and application performance
  • Implement application/page performance benchmarks and the testing framework to validate them
  • Experience with functional, regression, security, and performance testing
  • Experience as a QA engineer testing web-based ECOM applications
  • Hands on experience working in an Agile SDLC within the SCRUM framework is required
6

Responsibilities For Program Effectiveness & Quality Assurance Technical Director Resume

  • Possess a strong technology background, preferably in coding or operations
  • Oversee compliance and implementation of the FDA Current Good Manufacturing Practices
  • Recruits, trains, mentors, supervises, and evaluates staff while building an effective team dynamic
  • Influence and negotiate effective solutions
  • Supports the design, development and implementation of effective Quality Management Systems for Bioclinica’s Corporate-Wide
  • Strong work ethic and ability to self motivate
  • QA Automation, Load, Regression, and Performance Test Experience
7

Responsibilities For Director, Post-marketing Quality Assurance Resume

  • Experience in Web, and ideally Mobile Software Development and Lifecycles
  • Extensive knowledge and experience in cGMP'S
  • Partner with project management, COEs, and support to ensure effective QA methodologies are created and followed for each customer deployment
  • Experience being on development teams in different roles
  • Extensive knowledge and experience in GXP and QA principles, practices & industry standards
8

Responsibilities For Global Quality Assurance Director Resume

  • Limiting further processing or delivery of a nonconforming item or unsatisfactory condition until proper dispositioning is accomplished
  • Modeling Weir Group success values and behaviors and enforcing the company Code of Conduct
  • Reviewing new Editions of the ASME B&PV Code when required, and implementing necessary changes to the WVC quality assurance program in a timely fashion
  • Contributing to the long-term strategy development that supports business growth and change
  • Managing department budget and expenses per VF philosophy
  • Being a champion of all safety, health and environmental initiatives
9

Responsibilities For Corporate Quality Assurance Director Resume

  • Providing adequate inspection facilities to assure that verification of materials, items, and valve parts is properly executed
  • Contributing to the long term strategy development that supports business growth and change
  • Drive high levels of Quality Assurance team performance through recruiting, coaching and counselling employees; planning, monitoring, and appraising results
  • Promote employee development by actively engaging in coaching, mentoring, knowledge transfer, training, performance management and career development
  • Assume a strategic role in establishing and maintaining Nuance Document Imaging quality programs covering the complete SDLC
  • Managing and leading a growing team in a fast pace, agile environment
10

Responsibilities For Regional Director of Quality Assurance Resume

  • In depth understanding implementing automated regression testing with open source tools to shorten release times
  • Implement formal application performance testing, including defining performance benchmarks
  • Leads Business projects from initiation through implementation including phases such as planning, analysis, design, development, testing and implementation
  • Drive continuous improvement, including streamlining processes and developing robust automated test procedures
  • Responsible for reviewing and approving SOPs , batch records and ensuring the operation complies with GMP regulations
  • Provide leadership in developing and deploying expertise in Geometric Dimension and Tolerance (GD&T) throughout manufacturing and supply chain
  • Assist in reviewing, analyzing and documenting business and user requirements for technology product development
  • Quality Engineering Real Time Aging

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