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Quality Engineering Manager - Minneapolis, United States - Actalent
Description
:Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements. Assure compliance with respect to European Medical Devices Directive and Medical Device Regulation requirements as appropriate.
Responsible for product release process ensuring that contract manufactured product meets product specifications prior to approval and release.
Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements.
Perform duties of "Management Representative" to represent the company's quality system to outside regulatory agencies or certification bodies.
Assure that internal audits are scheduled, conducted and have appropriate responses. Assure audit findings are reported to management.
Schedule and conduct supplier audits.
Skills:
quality assurance, quality engineering, audit, medical device, regulatory, supplier quality, grand ave
Additional Skills & Qualifications:
Must Haves:
+ 10+ years in Quality Medical device
+ 3+ years in Quality Assurance
+ 3+ years in Quality Systems
Nice to Haves:
+ Regulatory
+ supplier management
+ incoming inspections
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.
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 ) for other accommodation options.