Eastridge Workforce Solutions is partnering with a recognized leader in the contract medical device industry in it search for a Principal Quality Engineer. Our Mansfield, MAclient is a medical device manufacturer, an expert in design, development, manufacturing, and assembly of complex ESM and disposable medical devices. This is an on-site, direct hire opportunity offering a Monday - Friday, 8 a.m. - 5 p.m. schedule.

Responsibilities

• Perform internal quality and design audits.
• Participate in medical product risk analysis.
• Plan, develop, and execute verification and validating testing for products under development.
• Participate in technical review of design input specifications and design documentation for new medical devices.
• Assist corporate management in implementing and maintaining a quality system that is
• compliant with ISO 13485 and FDA quality system regulation requirements.

Requirements:

• Bachelor of Science degree in Engineering or equivalent experience.
• 5+ years in medical device quality assurance.
• ASQC Certification desired.
• A working understanding of FDA Quality Systems regulations, EU Active Implantable and Medical Device Directives, and ISO-13485 principles.
• Working knowledge of IEC 60601 medical device safety standards and IEEE software quality standards is preferred.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply.Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds.

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