Senior Quality Engineer

Lumicity; Billerica (MA); On-site; USD 100,000 - 145,000; Full time

Job summary

A leading medical device company in Billerica is seeking a Quality Engineer to enhance their quality engineering team. The successful candidate will investigate and report device issues, handle customer complaints, and ensure regulatory compliance within FDA and ISO standards. With a focus on continuous improvement and supplier management, this role requires strong technical expertise and a relevant engineering degree.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 5+ years in Quality Engineering in medical device manufacturing, FDA/ISO regulated.
• Strong understanding of regulatory standards (FDA, ISO).
• Proficient in GD&T and technical writing.

Responsibilities

• Investigate and report adverse events per FDA and international regulations.
• Conduct root cause analysis and manage material disposition.
• Support CAPA processes and ensure compliance with cGMP.

Skills

ISO 13485

ISO 14971

FDA QSR

Blueprint reading

Technical writing

Quality auditing

Six Sigma

Lean

Education

Bachelor’s in Engineering, Science, or Math

Job description

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Thriving medical device company looking to add to their quality engineering team!

Key Responsibilities:

• Investigate, assess, and report adverse events and device issues per FDA and international regulations.
• Handle nonconforming materials and customer complaints; conduct root cause analysis, manage material disposition, and liaise with customers and suppliers.
• Lead supplier corrective actions (SCAR), coordinate with suppliers, and oversee resolution plans.
• Support CAPA processes: investigate, identify root causes, implement corrective actions, and verify effectiveness.
• Qualify and audit suppliers, monitor performance, and manage supplier scorecards and related activities.
• Drive Risk Management tasks and documentation.
• Conduct Gage R&R studies and validation work.
• Develop and apply statistical sampling plans for inspections/testing.
• Ensure compliance with cGMP, QSR, ISO 13485, ISO 14971, MDR, and related standards.
• Participate in internal/external audits and FDA inspections.
• Support Post-Market Surveillance (PMS) activities.

Minimum Qualifications:

• Bachelor’s in Engineering, Science, or Math.
• 5+ years in Quality Engineering in medical device manufacturing, FDA/ISO regulated.
• Strong understanding of ISO 13485, ISO 14971, FDA QSR, and EU MDR.
• Proficient in blueprint reading and GD&T.
• Experience in technical writing and quality auditing.
• Familiar with Six Sigma, Lean, and other continuous improvement tools.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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