Quality Engineering Senior

Senior Quality Engineer

Novozen Healthcare LLC

Employment Type: Contract

Review and disposition Non-Conformance Material Reports (NCMRs), investigate root causes, and implement corrective actions.

Lead CAPA activities, including root cause analysis, action planning, implementation, and effectiveness verification.

Collaborate with Validation Engineering on process and equipment validation activities.

Develop, review, and maintain inspection plans, inspection templates, and quality documentation for machining operations.

Apply GD&T principles to engineering drawings, inspection requirements, and manufacturing processes.

Provide hands-on shop-floor quality support for CNC milling and lathe operations used to manufacture components for hip implants.

Investigate manufacturing quality issues using statistical methods and structured problem-solving techniques.

Support process improvement and mini-CAPA initiatives related to measurement systems, machining, and product quality.

Partner with Manufacturing, Engineering, Validation, and Operations teams to maintain compliance with medical device quality and regulatory requirements.

Experience in medical device manufacturing or medical device quality engineering.

Experience in root cause analysis, nonconformance investigations, and corrective action implementation.

Ability to interpret engineering drawings and support inspection planning.

Willingness to provide shop-floor support for approximately 40% of the role.

Anticipated hourly pay range: $Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Retirement Benefits:

A 401(k) retirement savings plan is available. No PTO other than that required by applicable state and local laws.