Design Quality Engineer

Job highlights

• Occasional travel may be required to support product development activities,supplier visits,or audits. .
• . BS Degree or higher in engineering field required (e.g.,Electrical,Systems,Mechanical Engineering). .
• Experience with design,sustaining engineering,or medical device quality engineering required. . .

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. Client has operations in more than 40 countries around the world.

Job Title: Design Quality Engineer
Location: Remote
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Remote

Essential Duties & Responsibilities:

• Collaborate with R&D and cross-functional teams to support design control requirements throughout product development and lifecycle management.
• Support design verification and validation, risk management, and design reviews to help ensure applicable safety, performance, and regulatory requirements are met.
• Review engineering design changes and provide quality input to ensure appropriate documentation, traceability, and risk assessment.
• Support continuous improvement of design control processes, templates, and procedures to align with regulatory expectations and business needs.
• Participate in sustaining engineering projects, providing quality support to maintain compliance and support product improvements.
• Support complaint handling by reviewing complaint data, participating in root cause analysis, and identifying design-related trends or failure modes.
• Assist in preparing quality deliverables for regulatory submissions, including 510(k)s, technical documentation, and IDE-related documentation.
• Support internal and external audits by preparing relevant design history and risk management documentation.
• Collaborate with Regulatory Affairs, Operations, Manufacturing, and Quality Assurance to support consistent approaches to design quality.
• Support quality metric tracking and management review inputs related to design control and product quality performance.
• Perform other quality-related duties assigned by management, including but not limited to supporting CAPA investigations, nonconformance (NC) evaluations, data analysis, and continuous improvement initiatives.
• Occasional travel may be required to support product development activities, supplier visits, or audits.

Supervisory Responsibilities:

• This role does not have supervisory responsibilities.

Interaction:

• The incumbent works closely with various departments (e.g., QC, QA, Operations, Regulatory and within R&D).

Education and Experience:

• BS Degree or higher in engineering field required (e.g., Electrical, Systems, Mechanical Engineering).
• Experience with design, sustaining engineering, or medical device quality engineering required.
• Minimum 3 years experience in design, sustaining engineering, or medical device quality engineering required.

Knowledge, Skills, and Abilities:

• Working knowledge of ISO 13485, 21 CFR 820, EU MDR.
• Experience with Design Controls and risk management.
• Statistical knowledge and understanding of measurement uncertainty.
• Detail oriented, well organized and have excellent communication skills.
• Able to accomplish objectives with general supervision and escalate issues appropriately.

Physical Demands:

• Duties of this job may involve standing and/or walking, but for most part sitting for extended periods of time.
• Duties also involve daily keyboard data entry.
• Close vision and the need to focus on computer screen.
• Use of hands, fingers and wrist to type on keyboard and manipulate mouse.
• Will need to lift and move boxes of paper and binders weighing up to 20 pounds.

Work Environment:

• Typical office setting with a laboratory, offices, warehouse, and cubicles.
• Noise level is moderate with consistent printer, telephone ringing and conversation.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.