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Description:

• Large Medical Device company is looking for a Quality Systems Engineer. Develops strategy and leads Quality & Compliance functions for the business to maintain high state of compliance and ensuring business needs are met by providing appropriate oversight for day-to-day business and for business change initiatives.

• Works with other departments such as R&D, Regulatory, Supplier Quality, LCM, Marketing, Supply Chain to develop strategy

• Supports regulatory compliance audits.

• Conducts Quality System and Quality Manual development

• As needed, assist with creation and modification of Quality System procedures, work instructions and related documentation.

• Provides input and development of Intra Company Quality Agreements

• Ensures compliance with regulatory agency regulations and standards.

• Provides solutions to a variety of problems of moderate scope and complexity.

• Responsible for communicating business related issues or opportunities to next management level.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed

Skills & Qualifications:

Must

• A minimum of bachelor’s degree is required

• A minimum of 6-8 years of experience in related field and/or equivalent experience in the medical device industry is required.

• Experience with FDA regulations for medical devices is required.

• Experience with ISO 13485: 2016 is required.

• Knowledge of the European MDD, MDR and CE marking is required.

• Experience working as a member of a team in a timeline-driven environment with limited supervision is required.

• Good Quality Systems Knowledge

Plus:

• Project Management experience is preferred.

• Demonstrated leadership, organizational, and planning skills with the ability to work cross-functionally with a culturally diverse work force and customer base is preferred.

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.