What are the responsibilities and job description for the Quality Assurance Engineer II position at Quanterix?
Billerica, Ma
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 from around the globe to, 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 candidate to join our Quality Assurance team. This individual will be responsible for supporting Product Quality needs within the QA organization. The role will work with multiple groups within the organization to support efforts to analyze, prioritize, and communicate various product quality information to maximize customer satisfaction. These efforts will include addressing Continuous Improvement related activities WHAT YOU’LL DO:
Our Technology
WHY YOU’LL LIKE WORKING WITH US:
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 r easonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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 from around the globe to, 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 candidate to join our Quality Assurance team. This individual will be responsible for supporting Product Quality needs within the QA organization. The role will work with multiple groups within the organization to support efforts to analyze, prioritize, and communicate various product quality information to maximize customer satisfaction. These efforts will include addressing Continuous Improvement related activities WHAT YOU’LL DO:
- Works with Operations, Manufacturing, Quality Control and other stakeholders in analyzing and monitoring internal quality event data (i.e. NCRs & Deviations) to improve product quality and overall customer satisfaction
- Monitor corrective action activities with owners to help drive completion and closure
- Support manufacturing process improvement initiatives using quality disciplines and practices
- Collaborate with NPI teams with implementing and qualifying processes during new product development
- Facilitate Change Control Process related to manufacturing processes within scope of responsibility
- Review and approve change requests related to manufacturing and production process changes.
- Assist in driving risk analysis practices for assay manufacturing processes
- Support Batch Review activities
- Participate and support Internal Audit Program
- Conduct special projects as needed
- 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)
- 3-5 years of experience within the Medical Device, Biotechnology, Life Sciences or similar discipline arena
- Some knowledge of device regulations and quality system standards, including 21 CFR 820, ISO 9001, ISO 13485, ISO 14971, desired
- In-vitro diagnostic (reagents and instrumentation/software) experience
- Able to work with some daily guidance
- Good team participation skills
- Organized and detail oriented
- Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software,
- Strong work ethic and organizational skills with a collaborative attitude
- Hybrid
- Less than 10% Travel
Our Technology
WHY YOU’LL LIKE WORKING WITH US:
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 r easonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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