Senior Quality Engineer
Novozen Healthcare LLC · Vandalia, Ohio, United States
FULL TIME
Job Description
Title: Senior Quality EngineerCompany: Novozen Healthcare LLCLocation: Vandalia, OH (Fully Onsite)Employment Type: ContractDuration: 3–6 Months
Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.
Job ResponsibilitiesReview 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 QualificationsExperience 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 ScaleAnticipated hourly pay range: $44–$52/hr on W2.BenefitsEmployees 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. xzbcwsv Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.
Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.
Job ResponsibilitiesReview 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 QualificationsExperience 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 ScaleAnticipated hourly pay range: $44–$52/hr on W2.BenefitsEmployees 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. xzbcwsv Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.
Details
| Company | Novozen Healthcare LLC |
| Location | Vandalia, Ohio, United States |
| Type | FULL TIME |
| Niche | hr |