Job Description

Quality Engineer | Germantown, Wisconsin

Direct Hire | Onsite

A Kelly Engineering client has asked us to find a Quality Engineer to join their team to help develop quality systems, procedures, and controls that ensure medical products consistently meet performance and quality standards.

Duties/Responsibilities

• Identify, communicate, and implement quality improvements and solutions.
• Manage corrective actions, including customer complaints and internal issues:

- Investigate root causes using Lean, Six Sigma, and statistical tools.

- Coordinate sustainable corrective/preventative actions.

- Document findings and update customer portals and internal systems.

• Lead the non-conformance process:

- Evaluate suspect products and recommend disposition.

- Coordinate containment, returns (RMAs), and rework activities.

- Collaborate with customers on waivers or deviations.

• Maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory standards:

- Support internal and external audits and corrective actions.

• Contribute to product development and realization:

- Participate in design reviews, process planning, and risk analysis.

- Review key product characteristics, gaging methods, and GD&T.

• Review and approve Engineering Change Notices:

- Update quality documentation and control plans.

- Process supplier and customer change notices.

• Serve as manufacturing liaison for quality-related issues.
• Approve medical device releases:

- Conduct batch record reviews and generate Certificates of Analysis.

- Release products in ERP system per customer and internal requirements.

• Support manufacturing operations:

- Train personnel on inspection, rework, and customer specs.

- Oversee inspection and testing activities.

- Ensure customer approvals and maintain complete documentation.

Desired skills and experience

• BS in Engineering, Quality, or related technical field is preferred.
• 2-3 years of experience in a quality engineering role (within the medical device manufacturing environment is preferred)
• Understanding of quality standards and regulatory requirements: ISO 9001, ISO 13485, 21 CFR Part 820.
• Understanding of best practices for cleanroom gowning and cleanliness requirements for manufacturing within a cleanroom.
• Demonstrated experience in driving continuous improvement projects and using quality tools (e.g., DMAIC, 8D, PFMEA, SPC, MSA, DOE).

Client offers full benefits package not limited to:

• Medical, dental, and vision insurance
• PTO
• 401k retirement options

All applicants applying for this job opening must be legally authorized to work in the United States and are required to have US residency at the time of application. Sponsorship is not available for this opportunity. OPT or H1B Visa is not being accepted at this time.

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