AddressDescription
*******IMMEDIATE POSITION OPEN FOR A DESIGN CONTROL QUALITY ENGINEER********
Location: FOSTER CITY, CA
- Act as a Quality Engineer for medical device QMS quality improvement activities, with a focus on Design Controls and risk management.
- Provide oversight of quality improvement activities and ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and other applicable domestic/international regulatory requirements, including quality system requirements.
Top Skills Details:
- Risk Management
- Quality management system,
- ISO 13485, Medical Device
- Design Control
NEED EXPERIENCE:
• 3+ years of relevant experience in a GMP environment related field and a BS or BA. OR 4+ years of relevant experience and a MS.
• Knowledge and experience in quality assurance for development of drug-device combination products
• Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes.
• QA experience in both clinical and commercial combination products.
• Strong project management and process improvement skills.
• Demonstrates understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improve
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is preferred.
• Knowledge of Risk Management principles according to ISO 14971, including the use of risk management tools such as FMEA.
Experience Level:
Intermediate Level
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.
Diversity, Equity & Inclusion
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.
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