Quanterix
Quality Assurance Engineer II
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 a goal of significantly improving quality of life and longevity. We are on a mission to change the way 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 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 support Product Quality needs within the QA organization. The role will work with multiple groups to analyze, prioritize, and communicate product quality information to maximize customer satisfaction, including 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 (e.g., NCRs & Deviations) to improve product quality and 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
BASIC QUALIFICATIONS
Minimum of a Bachelor's Degree required in a 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 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
PREFERRED QUALIFICATIONS
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
EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES
Hybrid
Less than 10% Travel
WHY YOU'LL LIKE WORKING WITH US Our Technology : From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs made possible through its unparalleled sensitivity and flexibility. Simoa technology delivers the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins far below the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory support 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, 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 successes and failures.
We reward and recognize employees by offering competitive compensation, a 401k plan with employer match, health, dental, vision benefits, unlimited vacation for exempt, generous PTO for non-exempt, equity, employee stock purchase plan, performance bonus, 1:1 financial counseling/planning, tuition assistance, on-site fitness center, and free snacks and drinks daily.
DIVERSE & INCLUSIVE WORKPLACE Quanterix is committed to a diverse and inclusive workplace and strives to recruit candidates with inclusive mindsets aligned with 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.
#J-18808-Ljbffr
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 a goal of significantly improving quality of life and longevity. We are on a mission to change the way 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 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 support Product Quality needs within the QA organization. The role will work with multiple groups to analyze, prioritize, and communicate product quality information to maximize customer satisfaction, including 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 (e.g., NCRs & Deviations) to improve product quality and 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
BASIC QUALIFICATIONS
Minimum of a Bachelor's Degree required in a 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 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
PREFERRED QUALIFICATIONS
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
EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES
Hybrid
Less than 10% Travel
WHY YOU'LL LIKE WORKING WITH US Our Technology : From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs made possible through its unparalleled sensitivity and flexibility. Simoa technology delivers the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins far below the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory support 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, 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 successes and failures.
We reward and recognize employees by offering competitive compensation, a 401k plan with employer match, health, dental, vision benefits, unlimited vacation for exempt, generous PTO for non-exempt, equity, employee stock purchase plan, performance bonus, 1:1 financial counseling/planning, tuition assistance, on-site fitness center, and free snacks and drinks daily.
DIVERSE & INCLUSIVE WORKPLACE Quanterix is committed to a diverse and inclusive workplace and strives to recruit candidates with inclusive mindsets aligned with 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.
#J-18808-Ljbffr