Quality Engineer (Local candidates only)

firstPRO, Inc; Hudson (MA); On-site; USD 75,000 - 115,000; Full time

Job summary

firstPRO, Inc is seeking a hands-on Quality Engineer to join our Quality & Regulatory team, driving product quality, regulatory compliance, and continuous improvement in a medical device environment.

You will collaborate with manufacturing, engineering, operations, supply chain, suppliers, and contract manufacturers to review DHRs, NCRs, CAPAs, and MRB activities, and support supplier improvement initiatives.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related technical discipline.
• Quality engineering or quality assurance experience.
• Experience in regulated manufacturing (medical devices).
• Knowledge of NCR, SCAR, CAPA, MRB, inspection, and quality system processes.
• Experience with calibration, preventive maintenance, document control, and engineering change management.
• Experience with Agile PLM or similar PLM system.
• Strong technical writing and documentation skills.

Responsibilities

• Lead incoming and final inspection activities to ensure materials and finished products meet quality specifications.
• Review and approve Device History Records (DHRs), incoming inspections, product builds, and other quality release activities.
• Manage Nonconformance Reports (NCRs), SCARs, CAPAs, and MRB activities, including disposition of nonconforming materials.
• Conduct root cause analysis and support corrective and preventive actions to drive continuous improvement.
• Manage calibration programs for inspection tools, measuring devices, and test equipment.
• Oversee preventive maintenance schedules and ensure accurate quality and equipment records.
• Execute Engineering Change Orders (ECOs) and maintain controlled documentation through Agile PLM.
• Create, revise, and maintain manufacturing procedures, work instructions, travelers, and other quality documentation.
• Manage employee training records and assignments to ensure compliance with applicable procedures and work instructions.
• Partner with suppliers and contract manufacturers to resolve quality issues, implement corrective actions, and support supplier improvement initiatives.
• Assist with supplier audits and ensure approved changes are properly implemented.
• Collaborate with Engineering, Manufacturing, Operations, Supply Chain, and Quality teams to improve processes and product quality.

Skills

Quality Engineering

CAPA

MRB

NCR/SCAR

Agile PLM

Root Cause Analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Quality/Manufacturing/Life Sciences

Tools

Agile PLM

Job description

Make an Impact in Medical Device Quality

Our client is seeking a Quality Engineer to join our Quality & Regulatory team and play a critical role in maintaining product quality, strengthening quality systems, and supporting continuous improvement.

This is an excellent opportunity for a hands-on Quality Engineer who enjoys working cross-functionally and wants meaningful exposure to manufacturing, engineering, operations, supply chain, suppliers, and contract manufacturers. Reporting directly to the Director of Quality & Regulatory, you'll have the opportunity to make a direct impact on product quality, compliance, and operational excellence.

What You'll Do

• Lead incoming and final inspection activities to ensure materials and finished products meet quality specifications.
• Review and approve Device History Records (DHRs), incoming inspections, product builds, and other quality release activities.
• Manage Nonconformance Reports (NCRs), SCARs, CAPAs, and MRB activities, including disposition of nonconforming materials.
• Conduct root cause analysis and support corrective and preventive actions to drive continuous improvement.
• Manage calibration programs for inspection tools, measuring devices, and test equipment.
• Oversee preventive maintenance schedules and ensure accurate quality and equipment records.
• Execute Engineering Change Orders (ECOs) and maintain controlled documentation through Agile PLM.
• Create, revise, and maintain manufacturing procedures, work instructions, travelers, and other quality documentation.
• Manage employee training records and assignments to ensure compliance with applicable procedures and work instructions.
• Partner with suppliers and contract manufacturers to resolve quality issues, implement corrective actions, and support supplier improvement initiatives.
• Assist with supplier audits and ensure approved changes are properly implemented.
• Collaborate with Engineering, Manufacturing, Operations, Supply Chain, and Quality teams to improve processes and product quality.

What We're Looking For

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical discipline preferred.
• Quality Engineering or Quality Assurance experience.
• Experience working in a regulated manufacturing environment, preferably medical devices.
• Strong knowledge of NCR, SCAR, CAPA, MRB, inspection, and quality system processes.
• Experience with calibration, preventive maintenance, document control, and engineering change management.
• Experience with Agile PLM or a similar product lifecycle management system.
• Strong technical writing and documentation skills.
• Excellent analytical, organizational, and problem-solving abilities.
• Ability to work independently while effectively collaborating across multiple functions.

Preferred Experience

• Knowledge of ISO 13485 quality systems.
• ASQ Certified Quality Engineer (CQE) or similar certification.
• Experience conducting supplier audits and working with contract manufacturers.
• Familiarity with Device History Records (DHRs) and medical device manufacturing.

Why This Opportunity?

This is a highly visible role for a Quality Engineer who wants to be more than just a compliance resource. You'll have the opportunity to solve problems, improve processes, influence manufacturing quality, and work directly with cross-functional teams in a regulated medical device environment.