Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Deerfield, Illinois

Post: Fri, 09 Sep 2022 15:31:11 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

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—————————— Job Description ——————————

Roles & Responsibilities:

Provides Quality compliance input to the project team for project deliverables (e.g. Product Specifications, Risk Files, Design Reviews, V&V, Design Transfer, Clinical Evaluation Plans/Reports, etc..) and demonstrating commitment to patient safety and product quality.

Perform document reviews as Quality Reviewer to support EU MDR project activities such as design and labeling change controls.

Utilizes engineering and quality tools/methodologies (e.g. Six Sigma-DMADV DMAIC,…) to investigate complex and diverse product technical product problems and develop solutions which require critical, analytical, and creative thinking.

Understanding and working experience with medical device industry quality requirements associated with product development, design control, and product risk management.

Understanding and working knowledge of FDA regulation 21 CFR Part 820 and international regulations EN ISO13485 and EN ISO 14971

Familiarity with Medical Device Directive (MDD)/Medical Device Regulation(MDR) requirements for design control and product risk management

Strong communication skills (verbal and written) and team player

BS in Engineering with preference in Mechanical, Biomedical, or Chemical Engineering.

One to three years of Quality experience with preference in medical device industry.