Senior Quality Engineer

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time NH Facility 2XG, Northfield, NH, US — Requisition

Salary Range: $85,000.00 To $ Annually

The Senior Quality Engineer is primarily responsible for the following:

• Act as the voice of the customer (VOC).
• Lead Quality Assurance processes and ensure deliverables while mentoring Quality Engineers.
• Analyze quality processes for changes needed to assure standardization and consistency and report same.
• Assist and train employees in quality and improvement methodologies.

• Ensure Document Control team maintains a physical filing system for DHRs, change notices, and other QMS documentation, and maintaining digital Quality System filing structure.
• Train and mentor Quality Engineers on general quality processes, including: interpret specifications, implement GD&T; establish and document inspection methodologies; execute and document Gage Repeatability and Reproducibility; execute Process Failure Modes and Effects Analyses; execute Control Plans; execute Capability Studies; problem solving; technical writing; handling nonconforming product; scheduling and conducting cross‑functional problem‑solving collaborations; performing statistical analyses.
• CAPA/CARs / SCARs – responsible for assigned records through closure, including documenting investigations, root cause analysis, and action plans to prevent recurrence.
• Complaints – responsible for assigned records through closure, addressing customer expectations and potential escalation to CAPA/CAR.
• Establish and adjust inspection documentation and procedures while coordinating with Engineering and Document Control.
• Assist overall team to interpret specifications, blueprints, and purchase orders.
• Perform first‑article, final inspections, and other inspection duties as required.
• Perform Contract Review functions such as reviewing customer requirements and specifications.
• Perform review of Quality Agreements requested by customers considering impacts on other functions.
• Schedule and lead required Management Reviews.
• Supervise Quality Technicians and Quality Control team.
• Manage personnel with respect to performance reviews, hiring and orienting new employees, training, conflict resolution, and disciplinary actions.

• Identify, suggest, and lead changes to benefit the organization within the Quality System or Production.
• Ensure promotion of awareness of customer requirements throughout the organization.
• Ensure quality requirement flow down of customer purchase orders for products to be manufactured.
• Identify quality system needs, including inspection materials, tools, and equipment necessary and convey to Quality Manager for strategic planning and budgeting.
• Work with Senior Quality Director and Engineering team to meet and exceed customer and ISO/FDA regulations.
• Represent the company during customer, internal, ISO audits, and FDA inspections.
• Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.

• Education:
  
  High school diploma or GED. Bachelor’s degree in a STEM field preferred but not required.
• Experience:
  
  5+ years of relevant quality assurance or managerial experience, or equivalent combinations of education and experience. Experience with Software Engineering is preferred. Experience with in a manufacturing, medical device company or other regulated environment preferred.
• Licenses, Certifications and Registrations:
  Industry recognized Quality certification(s) preferred but not required.

• Professional Development / On the Job Training
• Health and Wellness Benefits
• Clean, Friendly, Safe work Environment
• Recognition and Rewards Program
• Tuition Reimbursement
• Competitive Pay / Merit Increases
• 401k with Company Match
• Employee Assistance Program (EAP)