Senior Quality Engineer

Job Title: Senior Quality Engineer

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.

Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.