Sr. Quality Lab Specialist

Role Summary

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.

What You’ll Do

• 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, ISO15189, 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

BASIC QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

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

Why You’ll Like Working With Us

• Our Technology: From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility.
• Our Commitment to Employees: At Quanterix, our values are based on: Team, Innovation, Customer and Owner. We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents.
• Diverse & Inclusive Workplace: Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Pay Range

$100,000 - $120,000 per year