Quality Engineer (ISO 13484)

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

• Provide quality oversight and support for combination product development and commercialization activities.
• Maintain and support the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and other applicable FDA and international regulations.
• Partner with R&D, Engineering, Manufacturing, Regulatory, and Clinical teams to ensure quality requirements are incorporated throughout the product lifecycle.
• Support Design Control activities, including Design History File (DHF) documentation, design reviews, design verification and validation, and design changes.
• Assist with risk management activities, including product risk assessments, FMEAs, and implementation of risk controls.
• Review and approve quality and technical documentation, specifications, protocols, reports, and change controls.
• Support investigation of nonconformances, deviations, complaints, and CAPAs, including root-cause analysis and effectiveness checks.
• Participate in supplier qualification, supplier quality activities, and oversight of external manufacturing partners.
• Support internal and external audits and assist with preparation of responses to audit findings.
• Provide quality guidance to cross-functional project teams and help identify potential compliance risks early in the development process.
• Contribute to continuous improvement initiatives related to product quality, processes, and the overall QMS.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• 3+ years of experience in Quality Engineering within medical device, pharmaceutical, biotechnology, or combination product environments.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and 21 CFR Part 4.
• Experience with Design Controls, risk management, CAPA, nonconformance investigations, and change control.
• Experience working in a regulated GMP environment preferred.
• Strong technical writing, documentation, problem-solving, and communication skills.
• Ability to work effectively with cross-functional teams in a fast-paced product development environment.

Internal Job ID 10577

IND1