Quality Assurance Engineer

at Actalent in Wheeling, Illinois, United States

Job Description

Description:

QUALITY ASSURANCE ENGINEER

Will participate in the design, creation, implementation and monitoring of programs and methodologies to ensure that assigned products meet established specifications, design criteria and control, quality and regulatory standards and customer requirements. Provides sustaining and design control quality support for on-market products and products under development. Develops and provides leadership for Quality System processes.

Key Responsibilities and Duties

- Evaluate deviations, non-conformances, customer complaints and process/product change control for completeness and impact on quality for on-market products

- Review, consult and approve Risk Analysis

- Serve as Quality representative on product development teams responsible for Design Control requirements

- Provide leadership and guidance for developing equipment/product/process Verification & Validation Protocols

- Review records for product release and documents for completeness & accuracy under a production schedule

- Identify key performance metrics and develops reporting mechanism

- Identify, investigate and collaborate with other departments to resolve quality issues

- Lead continuous improvement opportunities and works cross-functionally to implement corrective/preventive actions

- Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products

- Support audits and inspections

Qualifications

- Bachelor’s Degree in life science or engineering discipline required

- 5+ Years’ experience in QA, Engineering or Scientist Role

- 5+ Year’s experience with change control and complex problem solving

- 3+ Years knowledge of cGMP regulations (21 CFR 820, ISO 13485)

- Knowledge of cGMP regulations (21 CFR 820, ISO 13485) preferred

- Certification in a quality discipline preferred, such as CQM, CQA, CQE

- Computer skills (Microsoft Windows and Office programs), familiarity with Oracle, preferred

- Demonstrated problem-solving and analytical skills

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.