Quality Assurance Specialist II, Device Design Control

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

About Terrestrial Bio, Inc.

Terrestrial is transforming the delivery of next‑generation therapies, starting with GLP‑1.

Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self‑administration, the temperature‑stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in‑vivo proof of concept across multiple molecules. For more information, visit www.terrestrialbio.com.

Why this role

The Quality Assurance Specialist II, Device Engineering will support Quality Assurance activities for Terrestrial's 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.

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.

What you'll do

• 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.

Who you are

• Minimum 4+ years of quality experience in medical devices, pharmaceuticals, biologics, or combination products within a cGMP‑regulated medical device or combination product environment.
• BS or MS in a related Life Science field preferred
• 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).

Compensation: The anticipated base salary range for this position is $75,000 - $95,000 . Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

Onsite expectations: The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.

Location: Woburn, MA until relocation to a new, custom facility in Allston MA planned for Q4 of 2026.

At Terrestrial, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.