DESIGN ASSURANCE QUALITY ENGINEER

DESIGN ASSURANCE QUALITY ENGINEER

SUMMARY:

Quality Engineer needed to support product development Design Assurance efforts for a medical device innovator.

DUTIES & RESPONSIBILITIES:

* Provide Quality Engineering and Design Assurance Support related to material specifications, inspections, drawings, manufacturing SOPs, and related testing, and help drive quality system development, implementation and compliance

* Oversee metrology, inspection, measurement systems and non-conformance activities, and provide leadership supporting QA plans, risk management, CAPA systems, and root cause analysis

* Review tech transfer plans and reports for design transfer compliance

* Team meetings and communications and production of relevant, compliant documentation.

* Other related duties, as required

QUALIFICATIONS & REQUIREMENTS:

* 4+ years of experience product development / R&D teams and excellent engineering and manufacturing knowledge related to new products

* 6 years of medical device quality assurance, including strong design assurance background

* Solid understanding of 21 CFR 820, ISO 13485, ISO14791 and other related regulatory and quality standards

* Proven experience with Minitab, FMEA risk assessment, and Statistical Process Control (SPC) for process improvement

* Experience reviewing design documentation (drawings, specifications, DHFs, test data sheets, etc.)

* Excellent written, verbal, and interpersonal communication skills

* Relevant BS degree

* Medical Device industry auditing experience is a plus, as are Quality and SIX-Sigma certifications