Quality Compliance Specialist

Job Description

Job Description

Join the Innovation Engine at Advanced Instruments, a part of Nova Biomedical

At Advanced Instruments, now proudly part of Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. As a global leader in analytical technologies for the biopharmaceutical and clinical markets, our solutions are trusted in over 100 countries to accelerate drug development and enhance patient care.

Together, we are united by a bold vision : to improve the health of every patient through innovation and excellence . Our mission is to deliver smart, science-driven solutions that optimize processes, increase efficiency, and ensure confidence in results—ultimately leading to better outcomes for patients and providers alike.

Our integration brings together over 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. From FDA-registered, ISO-certified manufacturing to 125+ FDA approvals and industry-trusted diagnostics, we set the standard for quality and reliability. Advanced Instruments is also the global leader in osmolality testing, with a legacy of innovation that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a growing global presence of 1,965 employees, we’re building an empowered, collaborative culture grounded in our shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity . We’re honoring our founder led legacies—and shaping a future defined by impact.

Explore what’s next with us at or

We are looking for a Quality Compliance Specialist who will provide support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. They also provide support for other functions such as Post-market Surveillance (PMS). The Quality Compliance Specialist will take primary ownership for complaints and post-market surveillance utilizing the Sales Force platform. You will conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause. You will promote a culture of quality focused on compliance with customer needs and regulatory requirements.

What we are looking for in you:

• Bachelor’s Degree in scientific/technical discipline

• Quality / Regulatory certifications is a plus

• 5-8 years related experience and/or training; or equivalent combination of education and experience.

• Experience with Salesforce and/or Epicor

• Must be able to use Microsoft Office, Adobe, as well as comfort in eQMS and ERP Company Software.

• Knowledge of ISO 13485, MDSAP and FDA QSR required, other regulatory jurisdictions strongly preferred.

• Experience with in vitro diagnostics (IVD / IVDR) is preferred, other applicable experience is a plus.

• Minimum 4 days onsite requirement to support the business, 1 day remote

Work Location: Norwood, MA

What's in it for you?

• Flexible Medical, Dental, & Vision Coverage

• Competitive 401k company match

• Bonus Program, Generous PTO and paid holidays

• Generous Tuition reimbursement

• Hybrid and flexible work arrangements

• Professional development, engagement and events

• Company marketplace for lunch and snacks!

EEO Statement:

Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Advanced Instruments will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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