Senior Quality Engineer

Senior Quality Engineer

Novozen Healthcare LLC

Vandalia, OH (Fully Onsite)

Employment Type: Contract

Duration: 3-6 Months

Job Responsibilities:

• 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.
• Perform and evaluate Gage R&R studies to assess measurement system capability and recommend improvements.
• 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.

Required Qualifications:

• Experience in medical device manufacturing or medical device quality engineering.
• Hands-on experience with CAPA, NCMR review, Gage R&R, and GD&T.
• Experience in root cause analysis, nonconformance investigations, and corrective action implementation.
• Ability to interpret engineering drawings and support inspection planning.
• Strong problem-solving and cross-functional collaboration skills.
• Willingness to provide shop-floor support for approximately 40% of the role.

Pay Scale:

• Anticipated hourly pay range: $44-$52/hr on W2.

Benefits:

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):

No PTO other than that required by applicable state and local laws.