Senior Quality Assurance Manager

Abcam; Waltham (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Abcam is seeking a dedicated Quality Assurance Manager to oversee its ISO certified Quality Management Systems in Waltham, Massachusetts. The role emphasizes regulatory compliance across research kits and IVDs while fostering a culture of continuous improvement. Join us to drive science forward and enhance customer satisfaction through strategic quality leadership.

Qualifications

• Minimum of 5 years in quality assurance within the medical device industry.
• At least 3 years in a managerial or supervisory role.
• Proficiency in ISO 9001, ISO 13485, and MDSAP standards.

Responsibilities

• Oversee Quality Management Systems at the Waltham site.
• Ensure compliance with ISO standards and facilitate quality improvements.
• Lead complaint investigations and manage QA coordinators.

Skills

Analytical Skills

Leadership

Quality Management

Regulatory Knowledge

Project Management

Education

Bachelor's degree in Quality Management, Engineering, Life Sciences, or a related field

Tools

Lead Auditor Certification

Job description

For over 25 years, Abcam has been providing tools the scientific community needs to enable faster breakthroughs in critical areas like cancer, neurological disorders, infectious diseases, and metabolic disorders.

We believe that to continue making progress, we need to work together, each bringing our own unique perspectives to make an impact on the world. This community needs people like you: dedicated, agile and above all audacious so we can truly drive science forward.

The Quality Assurance Manager is responsible for overseeing an ISO 9001 certified Quality Management System producing research kits and an ISO 13485 and MDSAP certified division producing Class I IVDs, ensuring compliance and excellence. The Quality Assurance Manager drives quality improvements for our customers across the Americas, fostering a culture of continuous improvement and operational excellence. The Quality Assurance Managers leadership will be pivotal in enhancing customer satisfaction and achieving organizational success.

This position reports to the Vice President of Global Quality Assurance and is part of the Quality Assurance team in Waltham MA and will be on-site. At Abcam, our vision is to be the most influential life sciences company for researchers worldwide.

In this role, you will have the opportunity to:

• 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.

The essential requirements of the job include:

• Education: Bachelor's degree in Quality Management, Engineering, Life Sciences, or a related field.
• Experience: Minimum of 5 years in quality assurance within the medical device or related industry.
• Leadership Experience: At least 3 years of experience in a managerial or supervisory role.
• Regulatory Knowledge: Proficiency in ISO 9001, ISO 13485, and MDSAP standards.
• Analytical Skills: Demonstrated ability to analyze data and proficient with analytical methods like Pareto Charts, Control Charts, Statistical Methods and Sampling Plans.
• Technical Proficiency: Lead Auditor Certification, experience leading investigations and CAPAs, and supporting validation plans, design, and production provision activities.
• Project Management: Experience leading Quality Plans, or Continuous Improvement projects to deliver on-time to defined specifications.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Travel: 5% travel – including potential internationally

It would be a plus if you also possess previous experience in:

• Experience with In Vitro Diagnostic medical devices
• Experience with Immunohistochemistry methods and evaluation

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [e-mail] to request accommodation.