About this position
Job Title: Senior Quality Engineer
Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply.
Company: Novozen Healthcare LLC
Location: Vandalia, OH (Fully Onsite)
Employment Type: Contract – 3–6 Months
Pay Scale: Anticipated hourly pay range: $44/hr to $52/hr on W2.
Job Responsibilities
- Review and disposition Non-Conformance Material Reports (NCMRs), including investigating root causes and implementing appropriate corrective actions.
- Lead and support Corrective and Preventive Action (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 where required.
- Collaborate with the Validation Engineering team on process and equipment validation activities to ensure compliance with medical device quality requirements.
- Develop, review, and maintain inspection plans, inspection templates, and quality documentation for machining operations.
- Apply Geometric Dimensioning and Tolerancing (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 chrome rods and components for hip implants.
- Investigate manufacturing and quality issues using root-cause analysis, statistical methods, and problem-solving techniques to prevent recurrence.
- Support process improvement and mini-CAPA initiatives, particularly those related to measurement systems, machining processes, and product quality.
- Collaborate with Manufacturing, Engineering, Validation, and Operations teams to ensure products and processes meet medical device quality, regulatory, and customer requirements.
- Spend approximately 40% of the working time on the shop floor supporting manufacturing and quality operations.
Required Qualifications
- Experience in medical device manufacturing and quality engineering.
- Hands-on experience reviewing and dispositioning NCMRs.
- Strong experience with CAPA, including root-cause analysis and effectiveness verification.
- Experience performing or reviewing Gage R&R studies and interpreting measurement system results.
- Knowledge of GD&T and engineering drawing interpretation.
- Experience supporting manufacturing quality operations, preferably in a machining environment involving CNC milling and lathe operations.
- Experience developing inspection plans, inspection templates, and quality documentation.
- Ability to collaborate with manufacturing, engineering, and validation teams.
- Willingness to work fully onsite in Vandalia, OH and provide hands-on shop-floor support.
- Ability to provide two professional references.
Pay Scale
Anticipated hourly pay range: $44/hr to $52/hr on W2.
Benefits
Employees hired into this position are eligible for the following benefits, subject to 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. xavwley
Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.
Location and commute
323 James Bohanan Dr, Vandalia, OH 45377.
Plan your route with Google Maps. Travel times and transportation options vary; confirm the work location with the employer before commuting.
How to apply
Review the vacancy and complete the application on the employer or recruitment partner’s website. Requisition ID: WJ-3207204820.