Sr. Quality Lab Specialist

Senior Quality Lab Specialist

Bedford, MA

We are looking for a skilled and experienced Senior Quality Lab Specialist to join our Quality team in Bedford, MA. The Senior Quality Lab Specialist will ensure regulatory compliance, lead audits, and drive continuous improvement of our Quality Management System. This position will be onsite for training and has the potential to work a hybrid schedule.

• Responsible for establishing and maintaining a culture of trust and compliance with established Quality standards
• Participation on cross functional project teams to provide guidance to meet the Accelerator QMS.
• Ensure Accelerator Laboratory Service’s 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
• Oversee Internal Sample Tracer audits and other audits as needed
• Provide QA review support of SOPs, validation protocols and reports, deviations, and CAPAs
• Prepare and present quality audit reports for management
• Assist in administering an internal proficiency testing program
• Lead efforts to continuously improve existing Quality Management System

• Bachelors Degree in life sciences (Medical Technology, Chemistry, Biology or biomedical engineering)
• 7+ years of experience in a Quality role supporting a regulated medical device, IVD, or pharmaceutical company QMS

• 5 years of experience in a Quality role supporting CLIA, ISO 15189, or GCLP
• Experience conducting Quality audits

We reward and recognize our employees by offering competitive compensation and a 401(k) plan with 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 eligible for equity, 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. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

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.