Quality Assurance Specialist II

7 days ago

Billerica, Massachusetts, United States Quanterix Full time
Quality Assurance Specialist

Quanterix is a leading company in the field of biomarker analysis, aiming to advance the science of precision health. Our ultra-sensitive detection solution, Ssimoa, has the potential to revolutionize the way healthcare is provided today. We are seeking an experienced and highly motivated Quality Assurance Specialist to join our Accelerator Laboratory in Billerica, MA.

Key Responsibilities:
  • Establish and maintain a culture of trust and compliance with established Quality standards
  • Participate in cross-functional project teams to provide guidance on meeting Accelerator QMS requirements
  • Ensure Accelerator Laboratory Services' compliance with CLIA regulations, ISO 15189, and GCLP guidelines through the assessment of established Quality Systems and education and training of laboratory staff in Quality Principles
  • Understand the IVD Development process and supporting standards, e.g. 21 CFR 820, ISO 13485, ISO 14971, cGXP guidelines
  • Oversee Internal Sample Tracer audits and other audits as needed
  • Provide Quality review of SOPs, validation protocols and reports, deviations, and CAPAs
  • Assist in administering an internal proficiency testing program
  • Play a lead role in design history and manufacturing audits
  • Lead efforts to continuously improve existing Quality Management System
  • Provide QA support of quality events, including deviations, Change Control and CAPAs
Requirements:
  • Bachelor's Degree in life sciences (Medical Technology, Chemistry, Biology or biomedical engineering)
  • 2+ years of experience in a Quality role supporting a regulated medical device, IVD, or a Pharmaceutical company
Preferred Qualifications:
  • 1 year of experience with vendor qualification
  • 3 years of experience in a Quality role supporting CLIA, ISO 15189, or GCLP
  • In-vitro diagnostic (reagents and instrumentation/software)
Why Join Us:

At Quanterix, we take pride in our employees' incredible work ethic and want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day.

Quanterix is committed to a Diverse and Inclusive workplace. 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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