Quality Assurance Manager

BioTalent; Marlborough (MA); On-site; USD 130,000 - 155,000; Full time

Job summary

A leading company in the medical equipment manufacturing sector is seeking a Quality Manager to oversee quality assurance and control functions for in vitro diagnostic medical devices. This role involves ensuring compliance with regulatory requirements and maintaining the quality management system. The ideal candidate will have extensive experience in quality management within the medical device industry and will collaborate with cross-functional teams to drive product and process quality.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Minimum of 5–8 years of quality experience in the medical device or IVD industry.
• Strong knowledge of QSR (21 CFR Part 820), ISO 13485, and EU IVDR requirements.

Responsibilities

• Oversee the implementation and improvement of the Quality Management System.
• Lead and manage quality assurance and quality control personnel.
• Manage internal and external audits, including FDA inspections.

Skills

Quality Assurance

Regulatory Compliance

Six Sigma

Education

Bachelor’s degree in a scientific, engineering, or technical discipline

Advanced degree preferred

Tools

CAPA

FMEA

Root Cause Analysis

Job description

This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$130,000.00/yr - $155,000.00/yr

Direct message the job poster from BioTalent

RA/QA Medtech & Life Sciences Recruitment for New England

Position Summary:

The Quality Manager is responsible for leading and managing the quality assurance and quality control functions for our in vitro diagnostic (IVD) medical device product lines. This role ensures that products are developed, manufactured, and distributed in compliance with applicable regulatory requirements (e.g., FDA QSR, ISO 13485, IVDR) and internal quality standards. The Quality Manager will play a key role in maintaining and continuously improving the quality management system, driving product and process quality, and supporting regulatory submissions and audits.

Key Responsibilities:

• Oversee the implementation, maintenance, and continuous improvement of the Quality Management System in compliance with ISO 13485, 21 CFR Part 820, and EU IVDR.
• Lead and manage quality assurance and quality control personnel.
• Review and approve quality documents, including SOPs, batch records, deviations, CAPAs, nonconformances, and validation protocols/reports.
• Support design control activities and risk management (ISO 14971) for new product development and changes to existing products.
• Manage internal and external audits, including FDA inspections, notified body audits, and supplier audits.
• Monitor and report quality metrics and key performance indicators (KPIs).
• Support the complaint handling and post-market surveillance processes.
• Ensure proper document control, training, and change control practices are in place and followed.
• Collaborate with cross-functional teams including R&D, Regulatory Affairs, Manufacturing, and Supply Chain to ensure product and process compliance.
• Serve as the Quality representative on project teams, providing guidance on regulatory and quality requirements.

Qualifications:

• Bachelor’s degree in a scientific, engineering, or technical discipline; advanced degree preferred.
• Minimum of 5–8 years of quality experience in the medical device or IVD industry.
• Strong knowledge of QSR (21 CFR Part 820), ISO 13485, and EU IVDR requirements.
• Proficiency in quality tools and methodologies (e.g., CAPA, FMEA, root cause analysis, Six Sigma).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at BioTalent by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified when a new job is posted.

Sign in to set job alerts for “Quality Assurance Manager” roles.

Lexington, MA $120,000.00-$140,000.00 2 months ago

Sutton, MA $90,000.00-$100,000.00 1 week ago

Supervisor, Quality Assurance and Control, Gas Operations

Senior Manager / Associate Director, Clinical Quality Assurance (no agencies please)

Chelmsford, MA $160,000.00-$175,000.00 5 days ago

Sr. Quality Assurance Manager - Manufacturing/Med Device

Quality Assurance Senior Manager, Technical Life Cycle Management (Cell and Genetic Therapies)

Manager, Food Safety and Quality Assurance

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