Title: Senior Quality Engineer
Company: Novozen Healthcare LLC
Location: 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.
Senior Quality Engineer in Vandalia at Novozen Healthcare LLC
This position is listed as contract and onsite. It was posted 3 days ago.