Senior Design Quality Engineer

Senior Design Quality Engineer

Billerica, Massachusetts

Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of life and longevity. We are 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.

To make this vision a reality, we brought together the most experienced management team, renowned scientists, industry leading investors and expert advisors, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health.

ROLE SUMMARY:

We are looking for an experienced and motivated Senior Design Quality Engineer to join our Quality Assurance team. This role will provide Quality Engineering support transitioning our HD-X platform from Research to the Diagnostics marketplace. The Senior Design Quality Assurance Engineer, with instrumentation focus, develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet Quanterix, customer, and regulatory requirements. It serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, and corporate quality goals and priorities.

WHAT YOU'LL DO:

• Support the New Product Development process to ensure design projects comply with internal design control procedures.
• Apply knowledge of Design Control and Quality Engineering principles to positively influence new product development efforts, including those for Voice of the Customer, establishing design inputs/outputs, Design Verification & Validation, Process Qualification & Validation, and Risk Management.
• Work with Assay Development, Instrument engineering, Operations, Service and other teams as needed to support vendor qualification, software validation, instrument IQ/OQ/PQ and assay system validation.
• Assess post launch purposed design changes to determine impact on risk level, verification and/or validation testing.
• Maintain Risk Management Files in compliance with regulatory requirements and local procedures.
• Provide support was external compliance requirements such as Safety, EMC, RoHS, China RoHS, WEEE, and Cybersecurity.
• Support other quality and compliance activities as required including supporting regulatory submissions, internal audits and inspections.
• Help to drive and foster a quality environment and mindset throughout the business.
• Support special projects as needed.

BASIC QUALIFICATIONS:

• 5+ years' experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline arena desired.
• Minimum of a Bachelor's Degree required in related field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent), Advanced degree is a plus (M.S. in a Life Science, or equivalent).
• Experience supporting regulated medical devices, diagnostics, life sciences, or related healthcare products.
• Experience with instrumentation, software, reagents or a combination of these technologies is preferred.

PREFERRED QUALIFICATIONS:

• Familiarity with one or more applicable medical device regulations and standards, such as ISO 14971, ISO 13485, EN61010, IEC 62304, IVDR and 21CFR820.
• Able to work independently.
• Excellent cross-functional team participation skills.
• Highly organized to manage multiple projects and detail oriented.
• Proficiency with standard business tools: word processing, presentations, spreadsheets, manufacturing software, database software.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:

• Billerica, Massachusetts (Hybrid)
• Travel less than 10%
• Experience using eQMS tools; Mastercontrol, Arena, TrackWise, etc.

WHY YOU'LL LIKE WORKING FOR US:

Our Technology :

From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Our Commitment to Employees:

At Quanterix, our values are based on: Team , Innovation, Customer and Owner .

Team : Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards

Innovation : Stay curious, experiment, create and change

Customer : Prioritize and celebrate these pioneers by doing our best to deliver on commitments

Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.

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. 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!

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.


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.

Pay Range: $125,000 - $150,000 per year