Job Description
Job Description
Job Title:Quality Engineer
Location: Rochester, MA, US (must be local)
Reports To: Quality Operations Manager
Salary Range: $90,000 to $110,000
Perks: Generous Bonus 5% , Excellent Benefits, and 401(k)
Job Summary:
A leading manufacturer of disposable medical products is seeking a Quality Engineer to support its Quality Management System (QMS) and ensure compliance with regulatory and procedural requirements. This position plays a key role within the Value Stream Business Unit, assisting in the implementation and oversight of quality programs to ensure process and product compliance under ISO and FDA regulations.
Key Responsibilities:
· Ensure compliance with ISO 13485:2016, 21 CFR Part 820, MDD, and internal Quality System requirements.
· Serve as the primary quality interface for assigned customers and suppliers.
· Monitor customer complaints and trends; conduct failure investigations and recommend corrective actions.
· Provide quality support on existing products/processes, including NCMRs, MRBs, root cause analysis, deviations, test procedures, and protocols.
· Conduct product and process risk analysis per ISO 14971.
· Create Quality Plans and Master Validation Plans for new product implementation.
· Develop and execute validation and verification protocols for cleanroom production.
· Manage customer quality documentation through the release process.
· Present key performance metrics during customer business reviews.
· Support Notified Body and customer audits; participate in supplier audits as needed.
· Investigate and resolve internal, customer, and supplier quality issues.
· Collaborate with Engineering and Manufacturing to establish product and process controls.
· Lead root cause failure analysis efforts for products, processes, and components.
· Drive corrective and preventive actions (CAPAs) to completion.
· Evaluate and approve changes to the Quality Management System, validations, and deviations.
Required Skills and Qualifications:
· Deep knowledge of ISO 13485:2016 and FDA QSR under 21 CFR Part 820.
· Familiarity with EEC Medical Device Directives and applicable product standards.
· Proficient in ISO 14971 risk and hazard assessment.
· Strong statistical analysis skills; Minitab proficiency required.
· Skilled in root cause analysis tools (e.g., Fishbone Diagrams, Fault Tree Analysis).
· Excellent written and verbal communication skills.
· Proficient in Microsoft Office (Word, Excel, PowerPoint, Visio).
· Strong presentation and training capabilities.
Education and Experience Requirements:
· BS in Engineering, Biology, or a related scientific field.
· Minimum of 4 years’ experience in medical device manufacturing as a Quality Engineer.
Certifications preferred:
· Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA).
Screening Questions for Quality Engineer Candidates:
- Are you currently located in or willing to relocate to Rochester, MA? (Location is a must-have requirement.)
- Do you have at least 4 years of experience working as a Quality Engineer in a medical device manufacturing environment?
- Are you knowledgeable and experienced with ISO 13485:2016 and FDA 21 CFR Part 820 regulations?
- How familiar are you with ISO 14971 and conducting product/process risk assessments under this standard?
- Have you used Minitab or other statistical analysis tools in a professional setting? If so, please briefly describe your experience.
- Can you describe your experience with root cause analysis tools such as Fishbone Diagrams or Fault Tree Analysis?
- Have you ever led or supported Notified Body or customer audits? If yes, please provide an example.
- Do you hold any quality-related certifications such as CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor)?