Quality Assurance Specialist II, Device Engineering

Terrestrial Bio; Woburn (MA); On-site; USD 85,000 - 105,000; Full time

Job summary

Terrestrial is seeking a Quality Assurance Specialist II, Device Engineering to support QA activities across our combination product programs. The role focuses on design controls, risk management, and cGMP compliance in early clinical development.

Reporting to the QA Manager, you will work cross‑functionally with Manufacturing, Process Development, Quality Control, and Material Management to ensure product quality and safety. Strong documentation and communication are essential.

Qualifications

• 4–5 years of quality experience in medical devices, pharmaceuticals, biologics, or combination products within a cGMP‑regulated environment.
• Working knowledge of ISO 13485 and FDA 21 CFR 820; familiarity with combination product requirements is preferred.
• Experience supporting early‑phase product development is desirable.
• Experience with design controls, risk management (FMEA), and validation activities preferred.
• Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports.

Responsibilities

• Support quality oversight of Terrestrial’s combination product(s) to ensure safety, efficacy, and regulatory compliance.
• Administer and support the QMS in accordance with ISO 13485 and 21 CFR 820, Part 4 and applicable FDA regulations.
• Provide quality support for Design Control activities, including DHF maintenance, design reviews, DVV, and design changes.
• Support risk management activities, including development and maintenance of risk analyses and linkage to design and process controls.
• Support process validation and qualification activities, including TMV, PV, and equipment qualification for Phase I and GMP‑ready manufacturing.
• Participate in MRB activities, including nonconformance assessment, disposition, and documentation.
• Perform quality review and approval of batch records, experimental reports, and data collection forms.
• Collaborate in supplier quality management activities, including supplier qualification, auditing, and requalification.
• Author, review, and revise quality documentation and specifications.
• Prepare and organize quality data for regulatory submissions and inspections.
• Contribute to continuous improvement initiatives within the QMS, including CAPA and deviation investigations.

Skills

Quality concepts

Documentation

MS Office

Communication

Quality assurance

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Quality Assurance Specialist II, Device Engineering

Terrestrial (formerly known as Vaxess) is developing a pipeline of next-generation vaccines and therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the self-applied patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Terrestrial is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role:

The Quality Assurance Specialist II, Device Engineering will support Quality Assurance activities for Terrestrial’ combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands‑on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4). Reporting to the Quality Assurance Manager, this role works cross‑functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development.

Responsibilities:

• Support quality oversight of Terrestrial’s combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements.
• Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations.
• Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes.
• Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls.
• Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP‑ready manufacturing.
• Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation.
• Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports.
• Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification.
• Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications.
• Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections.
• Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics.

Qualifications:

• 4–5 years of quality experience in medical devices, pharmaceuticals, biologics, or combination products within a cGMP‑regulated medical device or combination product environment.
• Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred.
• Experience supporting early‑phase (preclinical to Phase I) product development is highly desirable.
• Experience with design controls, risk management (FMEA), and validation activities preferred.
• Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports.
• Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

The anticipated base salary range for this position is $85,000 - $105,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.