QA Specialist II: Medical Devices & Combination Products

Terrestrial Bio, Inc.; Woburn (MA); On-site; USD 75,000 - 95,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Quality Assurance Specialist II in Device Engineering to support quality activities across design controls, risk management, batch record reviews, and supplier quality for combination products during early development.

Responsibilities include maintaining the QMS per ISO 13485 and FDA regulations, performing DHF reviews, conducting risk analyses, and contributing to continual improvement within the product development lifecycle.

Qualifications

• Minimum 4+ years quality experience in medical devices or combination products.
• Experience with design controls, risk management and validation activities.
• Experience reviewing GMP documents and batch records.

Responsibilities

• Support quality oversight of combination products for safety, efficacy and regulatory compliance.
• Administer and support the QMS per ISO 13485 and 21 CFR 820.
• Provide quality support for Design Control activities including DHF maintenance and reviews.
• Assist risk analyses (FMEA) and link to design and process controls.
• Support PV, TMV, and equipment qualification for Phase I and GMP-ready manufacturing.
• Participate in MRB activities including nonconformance disposition.
• Review batch records, manufacturing records, test records and reports.
• Collaborate in supplier quality management including audits and requalification.
• Author and revise SOPs, work instructions, test methods and protocols.
• Prepare data for regulatory submissions and inspections.
• Contribute to CAPA, deviations, and quality metrics improvement.

Skills

Quality Assurance

cGMP

ISO 13485

Regulatory knowledge

Documentation

Cross-functional

Education

Life Science degree

Job description

Terrestrial Bio, Inc. is seeking a Quality Assurance Specialist II in Device Engineering to support quality activities across design controls, risk management, batch record reviews, and supplier quality for combination products during early development.

Responsibilities include maintaining the QMS per ISO 13485 and FDA regulations, performing DHF reviews, conducting risk analyses, and contributing to continual improvement within the product development lifecycle.