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Job Title: SR. Quality Systems Engineer

Job Description

As a Sr. Quality Systems Engineer, you will report directly to the Sr. Director Quality in a rapidly growing organization providing Medical Device and Combination Product development Services. You will be responsible for the eQMS introduction and continual improvement of the current QMS standards and performance. You will be a key contributor towards the strategy for the QA department concerning all matters relating to the QMS and work cross-functionally with Engineering, Quality, Regulatory, & Project Management to ensure effective coordination of the quality processes across the organization. Your accountabilities will include leading the transformation from paper-based to eQMS, participating in data preparation and reporting, establishing performance standards and best practices within the QMS, and maintaining ISO13485 certification. You will also be responsible for Supplier Quality Management, QMS and Quality related training & coaching, and supporting Clients services with QMS consulting for Medical Devices & Combination Devices.

Hard Skills

• QMS

• eQMS System setup and maintenance

• Expert knowledge and interpretation of ISO :2016 and 21CFR820

• Minimum of 7 years of experience in QMS activities across the Medical Device Product Life Cycle

• Strong knowledge of Regulation (EU) 2017/ 745, MDSAP, GDP, GLP and GMP

• Experience in Design Control & Product Development

Soft Skills

• Strong communication

• Coordination

• Leadership

• Strategic planning

• Cross-functional collaboration

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.