Supplier Quality Engineer II

Company: Quanterix
Location: Billerica
Posted on: May 28, 2023

Job Description:

Quanterix is a company 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. In our focused therapeutic areas, our revolutionary technology, Simoa -, is helping researchers advance the science of precision health. Simoa - is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. We are hiring a Supplier Quality Engineer II located in Billerica, MA.
We are looking for an experienced and motivated candidate to join our Quality Assurance team. This individual will be responsible for supporting Quality needs within the Quality organization. The role will work with multiple groups within the organization to support efforts to gather, analyze, prioritize and communicate various quality information to maximize customer satisfaction.
What You'll Do:

• As a vital part of the Quality Assurance Team you will support the processes for qualifying new suppliers, analyze and improve supplier performance, implement corrective actions or quality plans internally
• Work closely with the Procurement team to select, qualify and develop suppliers by performing initial and periodic follow-up assessments/audits and assess suppliers
• Performing supplier audits
• Overseeing Calibration and Internal Audit Programs
• Maintain and report relevant supplier performance metrics to demonstrate the efficiency of the supplier quality process and management of potential risks
• Ensure the Supplier Quality function operates according to procedures and provides direction to other departments
• Review and approves supplier records: contracts, quality plans, change requests, CAPAs, NCRs, verification and validation protocols and reports
• Maintain supplier agreements and drive suppliers to improve quality of deliverables (defect capture and corrective action)
• Supports reporting trends in complaints and customer satisfaction
• Providing support for the ongoing retention of our ISO 9001 certification
• Establishing methods for inspection which can include the generation of Inspection Plans and Work Instructions
• Supports reporting on top product quality trends & issues
• Supports Assay Development, Engineering, Quality Control and Service groups to prioritize and maximize the impact of product quality improvement projects
• Supports Assay Development, Engineering, Quality Control and Service groups to identify opportunities to drive efficiency and effectiveness of product quality
• Supports Sales, Service, Program Management and other functions to ensure product quality data is well communicated and well understood by all key stakeholders What We'll Expect From You:
  • Bachelors Degree required, Advanced degree is a plus (M.S. in a Life Science, MBA or equivalent)
  • Professional certification is desired (i.e. Six Sigma, ASQ certifications, PMP)
  • 2-4 years experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline arena desired
  • In-vitro diagnostic (reagents and instrumentation/software) experience desired as is awareness of QSR and ISO 9001: 2015 Quality Management System
  • Able to work independently, with minimal daily guidance
  • Excellent cross-functional team participation skills
  • Highly organized and detail oriented
  • Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software
  • Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must
    Why You'll Like Working For Us:
    Our Technology: Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com .
    Our Commitment To Employees: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free bagels every Monday morning, and free snacks and drinks every day! Quanterix hosts Virtual Bingo nights with all employees when we can see families, pets, and win amazing prizes. Unwind on Tuesdays and Thursdays with a virtual yoga session. In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Maternity & Paternity leave, Family Medical Leave, Fertility Assistance, Dependent Care, Military Leave and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance.
    Quanterix is committed to a Diverse and Inclusive workplace. 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.
    #LI-JV1 #QISJ

Keywords: Quanterix, Billerica , Supplier Quality Engineer II, Engineering , Billerica, Massachusetts