Quanterix is a company on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping researchers advance the science of precision health. Simoa® is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. To continue our extraordinary growth, we are hiring a Senior Quality Systems Engineer (CAPA) located in Billerica, MA.  

We are seeking an experienced and motivated candidate to join our Quality Assurance team. This individual will be responsible for the coordination, tracking and trending of CAPA metrics across the Quanterix portfolio. This person will track and trend CAPA metrics and work with the business to close out CAPA actions in a timely manner. This person will also support maintenance of company compliance with quality system regulations and support efforts to improve the existing Quality Management System.

What You’ll Do:

• Ensure CAPAs are thoroughly documented to meet all requirements of 21CFR Part 820, IVDD, IVDR, ISO13485, ISO9001, particularly those associated with IVD products.
• Ensure all Corrective and Preventative actions (CAPAs) are implemented per company procedure and advise teams on how to successfully complete process.
• Perform reviews of IVD (and related) CAPAs to ensure they are being assessed appropriately for 21 CFR Part 820, IVDD, IVDR, ISO 13485 compliance.
• Drive regular cross-functional meetings to ensure CAPAs are being reviewed and addressed in a timely fashion in accordance with the company goals and regulatory requirements.
• Provide prompt escalation of "at risk" CAPAs to Quality Management.
• Ensure CAPA procedures are maintained to current and reflect the latest requirements of 21 CFR Part 820, IVDD, IVDR, ISO13485, ISO9001.
• Support regular KPI reporting efforts related to overall health of various products, programs and QMS, including CAPA status.
• Provide QMS metrics, trend analysis and reports to identify key process improvements for CAPA.
• Support maintenance of company compliance with national and international Quality System regulations for research use only and medical devices, consistent with the strategic priorities of the business by evaluating current procedures and practices against these regulations and implementing improvements where necessary.
• Perform quality review of documents including work instructions, standard operating procedures, validation protocols and reports, SDS, incoming inspection documents, and parts/specs/items.
• Support Internal Audit Program, including conducting laboratory walkthroughs, participating in internal audits, and supporting timely resolution of observations and nonconformities.
• Support efforts to improve existing Quality Management System (QMS), including document revisions, user training, and supporting process improvements required for compliance with applicable regulatory standards 21CFR Part 820, IVDD, IVDR, ISO13485, ISO9001.
• Provide QA support of investigations, including non-conformances (NCMR’s), SCARs, CAPA, root cause analysis, complaints, out-of-specification and environmental excursions.

What We’ll Expect From You: 

• Bachelor’s degree in Engineering or in the Life Sciences.
• 5 to 8+ years of experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role.

• Strong knowledge of current regulatory requirements and quality and compliance processes in related industry.

• Considerable experience in CAPA development, management and resolution.
• Strong root cause analysis skills desired.
• Ability to document, understand, and facilitate resolution of complex technical issues in partnership with functional owners.
• Strong project management experience with proven track-record of tracking and trending data and ability to manage multiple, simultaneous projects to meet deadlines.
• Excellent organizational and communication skills.
• Solid work ethic and a superior attention to detail.
• Demonstrated strength working independently.
• Excellent team player with strong interpersonal skills.
• Experience working in a regulated environment (ISO, GLP, GMP, FDA) strongly preferred.
• Comfortable working in a fast-paced environment, balancing multiple projects, and keeping to tight deadlines.

Physical Demands:

• General office requirements, no heavy lifting required.

Travel Requirements:

• Very limited; <10% of time

Why You’ll Like Working For Us: 

Our Technology: Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

Our Commitment To Employees: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free bagels every Monday morning, and free snacks and drinks every day! Quanterix hosts Virtual Bingo nights with all employees when we can see families, pets, and win amazing prizes. Unwind on Tuesdays and Thursdays with a virtual yoga session. In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Maternity & Paternity leave, Family Medical Leave, Fertility Assistance, Dependent Care, Military Leave and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. 

Our Culture: Quanterix is committed to a Diverse and Inclusive workplace. We have a Diversity Program with Executive Sponsorship. Our core values are Accountability, Teamwork, Trust, and Transparency OR ATT2. Meet some of our team HERE. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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