Sr. Design Quality Engineer

POSITION SUMMARY:

The Sr. Design Quality Engineer (SDQE) is accountable for supporting new product development and provides quality oversight to the Research & Development (R&D) organization while working within a multi-functional team environment for medical devices. The SDQE will handle projects and tasks, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements. The SDQE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement.

PRIMARY DUTIES & RESPONSIBILITIES:

•Support concurrent engineering efforts as a participating design team member for product development projects representing quality assurance and the customer (supplier and end user)
•Responsible for creating and maintaining product and process risk management files to meet FDA and ISO standards.
•Leads device material qualification activities and product transfer activities to current and new suppliers.
•Responsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product.
•Provide Quality oversight and approval of qualification/validation/design controls activities.
•Liaison with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented.
•Leads root cause investigations and coordinates timely action implementation with the CAPA process.
•Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)
•Evaluates product changes and directs appropriate disposition of product through the company’s change control system.
•Reviews product and documentation non-conformances and recommends inspection, product and/or quality system modifications.
•Participates in hands on cadaver labs, quality system audits (FDA, ISO, Internal, etc.) Kaizens, and Rapid Improvement Events

Requirements

•Bachelor's degree in Engineering, Science, Technology or a related discipline
•5+ of progressive medical device engineering experience in Manufacturing, Development, or Quality Engineering
•Familiarity working within an FDA compliant Title 21 section 820 environment.
•Certified Quality Engineer preferred.

Additional information

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