Quality Compliance Specialist

Advanced Instruments, LLC; Norwood (MA); Hybrid; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a detail-oriented Quality Compliance Specialist to join their dynamic team in Norwood, MA. This role is pivotal in ensuring quality assurance through effective management of product complaints and compliance with regulatory standards. You will leverage your expertise in Salesforce and quality compliance to drive efficiency and accuracy in operations. The company promotes a culture of innovation and collaboration, offering a flexible work environment and opportunities for professional growth. If you are passionate about quality and compliance, this is the perfect opportunity to make a significant impact in the biopharmaceutical and clinical sectors.

Benefits

Flexible Medical, Dental, & Vision Coverage

Competitive 401k Company Match

Bonus Program

Generous PTO and Paid Holidays

Tuition Reimbursement

Professional Development Opportunities

Company Marketplace for Lunch and Snacks

Qualifications

• 5-8 years of related experience in quality compliance.
• Knowledge of FDA QSR and ISO standards is essential.

Responsibilities

• Support QA function by managing customer product complaints.
• Conduct preliminary investigations and trend analysis.

Skills

Quality Assurance

Regulatory Compliance

Salesforce

Microsoft Office

ISO 13485

In Vitro Diagnostics

Education

Bachelor’s Degree in Scientific/Technical Discipline

Quality/Regulatory Certifications

Tools

Salesforce

Epicor

eQMS Software

ERP Software

Job description

Join to apply for the Quality Compliance Specialist role at Advanced Instruments, LLC

4 days ago Be among the first 25 applicants

Join to apply for the Quality Compliance Specialist role at Advanced Instruments, LLC

Get AI-powered advice on this job and more exclusive features.

Innovate, Empower, Grow—With Advanced Instruments

For nearly 70 years, Advanced Instruments has been at the forefront of innovation, helping organizations enhance quality, achieve reliable outcomes, and boost productivity in the biopharmaceutical, clinical, and food & beverage industries. We don’t just develop cutting-edge technology—we empower our customers with solutions that drive efficiency, precision, and performance.

From Solentim, revolutionizing cell and gene therapy with advanced imaging and single-cell deposition, to OsmoTECH and OsmoPRO micro-osmometers, delivering accurate and reliable lab results worldwide, we set the standard for quality and reliability. Our Artel portfolio ensures precision in liquid handling through advanced validation, automation, and calibration tools. What sets us apart? With customer-centricity at our core, we take ownership, push boundaries, and collaborate to make a meaningful impact. Headquartered in Norwood, MA, with locations in UK and Westbrook, ME, our 340 employees worldwide are driving exciting growth this year.

Our Mission: To drive innovation that optimizes processes, increases efficiency, and delivers confidence in results.

Our Vision: To improve patient health through innovation and excellence.

If you're looking for a career where ingenuity, accountability, and collaboration fuel success, join us and be part of a team that’s shaping the future of our industry.

We are seeking a self- motivated, collaborative, and detail-oriented Quality Compliance Specialist to work in our Norwood, MA office to serve as a core team member of the growing quality assurance team.

A Day In The Life

The Quality Compliance Specialist provides 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 SalesForce 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 p romote 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.

Privacy policy

https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Finance and Sales

Referrals increase your chances of interviewing at Advanced Instruments, LLC by 2x

Sign in to set job alerts for “Compliance Specialist” roles.

U.S. Ethics & Compliance Transparency Operations Manager

Greater Boston $111,800.00-$175,670.00 1 day ago

Massachusetts, United States 21 hours ago

Regional Compliance Coordinator (Boston HQ)

Human Resources Compliance Specialist (Boston Police Department)

Greater Boston $150,000.00-$180,000.00 2 weeks ago

Regulatory Affairs and Compliance Manager, Part-time

Regional Compliance Coordinator (Boston HQ)

Deputy General Counsel, Commercial & Healthcare Compliance

Boston, MA $100,000.00-$225,000.00 1 month ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.