Quality Assurance, Complaint Coordinator

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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 solid growth, we are seeking a talented and highly motivated Complaints Coordinator to join our growing organization. 

This individual will be responsible for coordination of the escalated complaint management system, including potential reporting to authorities as appropriate. In addition, the QA Complaint Coordinator will support the routine management and coordination of ISO, QSR and cGMP compliant Quality Management Systems and provide support for quality compliance activities and initiatives.

 Key Responsibilities:

  • Ensure escalated complaints are thoroughly documented to meet all requirements of 21CFR Part 820, IVDD, IVDR, ISO13485, ISO9001, particularly those associated with IVD products.
  • Perform reviews of IVD (and related) complaints and inquiries to ensure they are being assessed appropriately for 21 CFR Part 820, IVDD, IVDR, ISO 13485 compliance.
  • Drive regular cross-functional meetings to ensure escalated complaints are being reviewed and addressed in a timely fashion in accordance with the company goals and regulatory requirements.
  • Ensure complaint and escalated complaint 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 escalated complaint status
  • 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.

 Skill and Knowledge Requirements:

  • Demonstrated experience with complaint management processes.
  • Demonstrated experience writing, reviewing and approving quality policies and standard operating procedures.
  • Ability to participate in groups resolving active quality issues or process improvement activities.
  • Ability to document, understand, and facilitate resolution of complex technical issues in partnership with functional owners.
  • Ability to handle multiple priorities and meet established deadlines.
  • Excellent interpersonal and written/verbal communication skills.
  • Excellent analytical skills, with demonstrated ability to assemble, analyze, and summarize quantitative data.
  • Strong root cause analysis skills desired.
  • Manufacturing process and software validation experience desired.
  • Good understanding of design control principles and quality standards of practice and federal quality regulations including 21CFR Part 820/IVDD/IVDR/ISO13485/ISO9001, and
  • Keen attention to detail.

Minimum Experience and Education:

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

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. 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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