Quality Engineer, Medical Devices & QMS Excellence

Commonwealth Sciences, Inc.; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Commonwealth Sciences, Inc. is seeking a Quality Engineer to provide oversight for combination product development and commercialization.

The role will maintain and support the QMS in compliance with ISO 13485, 21 CFR 820, 21 CFR Part 4, and other applicable FDA and international regulations. You will partner with R&D, Engineering, Manufacturing, Regulatory, and Clinical teams to ensure quality requirements are integrated throughout the product lifecycle.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• 3+ years in Quality Engineering within medical device or related environments.
• Experience with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 4.
• Experience with Design Controls, risk management, CAPA, and change control.
• Regulated GMP experience preferred.
• Strong writing and communication skills.

Responsibilities

• Provide quality oversight for combination product development and commercialization.
• Maintain the QMS in compliance with ISO 13485 and FDA regulations.
• Partner with R&D, Eng, Regulatory and Clinical teams to embed quality across the lifecycle.
• Lead Design Control activities, including DHF, design reviews, V&V, and changes.
• Support risk management, including risk assessments, FMEAs, and risk controls.
• Review and approve quality docs, change controls, and CAPA investigations.
• Assist with supplier qualification and external manufacturing partners.
• Support audits and respond to audit findings.
• Provide guidance to project teams and identify compliance risks early.

Skills

Quality engineering

Design controls

Risk management

CAPA

Change control

FDA/ISO compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Commonwealth Sciences, Inc. is seeking a Quality Engineer to provide oversight for combination product development and commercialization.

The role will maintain and support the QMS in compliance with ISO 13485, 21 CFR 820, 21 CFR Part 4, and other applicable FDA and international regulations. You will partner with R&D, Engineering, Manufacturing, Regulatory, and Clinical teams to ensure quality requirements are integrated throughout the product lifecycle.