Job Title: Senior Quality Engineer
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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. xhqgsiq
Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.
Senior Quality Engineer in vandalia at Unknown Company
This position is listed as contract and onsite.