Quality Engineer - Medical - Billerica

Billerica, Massachusetts Permanent USD100,000 - USD130,000 per year
  • Competitive Employee Benefits Package
  • Opportunity for Growth (Manager)

About Our Client

The client serves as a quality ambassador within the speciality products vision care division, aiming to enhance awareness, visibility, and communication regarding quality initiatives while supporting departmental, functional, site, divisional, and corporate quality goals and priorities. With a global presence, extensive research, development, manufacturing, and commercial capabilities, the candidate contributes to advancing eye health and improving the quality of life for millions worldwide.

Job Description

  • Develop, maintain, and review risk management files, pFMEAs, and validation processes for new and existing products and processes.

  • Manage NC/CAPA processes, including corrective action plans, verification, closure, and coordination of quality improvement initiatives.

  • Coordinate supplier quality management activities, including qualification, evaluation, investigations, and collaboration with external vendors.

  • Oversee batch record review, product disposition, and support site-level audits, including internal, external, supplier, and customer audits.

  • Apply systematic problem-solving methodologies to identify and resolve quality issues, ensuring the production of safe and effective medical devices.

  • Identify and implement opportunities for continuous improvement in quality systems and processes.

  • Interact and coordinate activities with other departments, vendors, and customers to support quality objectives and initiatives.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

· Bachelors degree required, preferably in Engineering, Science (Chemistry, Biology, Physics, etc) or Math (Statistics).

· 5+ years of experience in roles with increasing levels of complexity and scope.

· Experience in an FDA regulated manufacturing or industrial environment.

· Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and regulations.

· Technical skills and experience related to process validation, statistical methods, and risk management.

· Experience performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred.

· Lean manufacturing / Six Sigma helpul

· Strong cross-collaborator, effective coaching and mentoring skills

· Ability to work independently, well organized and self-driven.

· Excellent written and verbal communication skills.

What's on Offer

  • Impactful Contribution: Working with our client as a quality engineer offers the opportunity to contribute to the development and production of eye health products that directly impact millions of people worldwide, helping them improve and maintain their vision.

  • Professional Growth and Development: Our client provides a dynamic environment for quality engineers to enhance their skills and knowledge through exposure to cutting-edge technologies, collaboration with diverse teams, and involvement in continuous improvement initiatives, fostering professional growth and advancement opportunities.
    • Robust medical, dental and vision plans, including tax-advantaged health care and dependent care spending accounts
    • Generous three weeks' vacation per year, along with additional sick time and floating holidays
    • 401(k) Retirement program, including a substantial company match
    • Free access to wellness and mental health support through our Employee Assistance Program (EAP)
    • Six weeks of paid parental leave
    • Company-paid life insurance and disability income protection, with optional buy-up
    • Participation in our Employee Stock Purchasing Plan
    • Voluntary benefits such as group legal, ID theft protection and loan refinancing
    • Tuition support through our Educational Assistance Program

Jenny Ly
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Job summary

Engineering & Manufacturing
Sub Sector
Engineering Design and R&D
FMCG (Fast Moving Consumer Goods)
Contract Type
Consultant name
Jenny Ly
Job Reference