Abcam · 1 day ago
Quality Assurance Manager
Waltham, MA
Full-time
Onsite
Mid, Senior Level
$110K/yr - $120K/yr
5+ years expAbcam is a company that has been providing tools for the scientific community for over 25 years, focusing on enabling faster breakthroughs in critical areas of health. The Quality Assurance Manager is responsible for overseeing the Quality Management System, ensuring compliance with ISO standards, and driving quality improvements across the Americas to enhance customer satisfaction.
BiotechnologyLife Science
Responsibilities
Responsible and Accountable for the Quality Management Systems (QMS) at Abcam’s Waltham area site
Assure compliance with applicable regulations, including ISO 13485, 21 CFR 820, ISO 9001 quality standard requirements
Maintain knowledge of existing and emerging regulations, standards, and guidance documents and interpret regulatory rules or rule changes and ensure communication through corporate policies and procedures, and engaging training
Lead Quality complaint investigations and ensure timely closure for identified Corrective and Preventative Actions to improve overall complaint rate performance for all customers in the Americas
Direct management of QA Coordinators which develops capability and enables a high performing, engaged quality team
Lead the Quality deliverables at the site and influencing all relevant teams to deliver high performance and meet key QA targets through daily management and weekly reviews
Promote the development of a company-wide culture of quality assurance and understanding of key QMS elements
Qualification
Required
Bachelor's degree in Quality Management, Engineering, Life Sciences, or a related field
Minimum of 5 years in quality assurance within the medical device or related industry
At least 3 years of experience in a managerial or supervisory role
Proficiency in ISO 9001, ISO 13485, and MDSAP standards
Demonstrated ability to analyze data and proficient with analytical methods like Pareto Charts, Control Charts, Statistical Methods and Sampling Plans
Lead Auditor Certification, experience leading investigations and CAPAs, and supporting validation plans, design, and production provision activities
Experience leading Quality Plans, or Continuous Improvement projects to deliver on-time to defined specifications
5% travel – including potential internationally
Preferred
Experience with In Vitro Diagnostic medical devices
Experience with Immunohistochemistry methods and evaluation
Benefits
Paid time off
Medical/dental/vision insurance
Retirement Benefits
Company
Abcam
Abcam helps researches with breakthroughs in areas such as cancer, neurological disorders, infectious diseases, and metabolic disorders.
1001-5000 employees
H1B Sponsorship
Abcam has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (1)
2022 (1)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$335.74MKey Investors
HSBC
2023-08-28Acquired
2019-05-15Post Ipo Equity· $256.94M
2012-04-27Post Ipo Equity· $77M
Leadership Team
Gavin Wood
Chief Financial Officer
Recent News
Research and Markets
2025-11-04
MarketsandMarkets Research Pvt. Ltd.
2025-11-03
2025-10-24
Company data provided by crunchbase