Title: Senior Quality Engineer
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.