Senior Quality Engineer (3) - Medical Device - Tewksbury, MA

Tewksbury, Massachusetts Permanent USD90,000 - USD135,000 per year
  • Employee Stock Options & Generous Medical Benefits
  • Revenue increased by 20% last quarter

About Our Client

My client is a leading global company in the field of eye health, recognized for its comprehensive portfolio of products and a rich history spanning over a century. With a significant global presence and a workforce dedicated to innovation, my client is committed to advancing eye health worldwide.Last year, my client grew at roughly 20 percent in revenue with the expectations of completing similar growth this upcoming year. They support the development of new products supporting clinical studies and offering grants for studies within the field. They offer a wide range of products for their global portfolio.

They have a strong commitment to ESG, supporting programs to support the government and make their products more accessible to those in need.

Job Description

  • Develop and maintain risk management files and pFMEAs for process enhancements.
  • Assist in validations for both new and existing products, processes, and equipment.
  • Lead NC/CAPA teams by devising corrective action plans and ensuring their implementation.
  • Coordinate supplier quality management tasks, including qualification, evaluation, and investigations.
  • Oversee batch record review and product disposition processes.
  • Prepare for various audits, including internal, external, supplier, and customer audits.
  • Utilize problem-solving methodologies to address quality issues and ensure the safety of medical devices.
  • Drive continuous improvement initiatives.
  • Collaborate with other departments, vendors, and customers to coordinate activities.
  • Fulfill additional Quality System responsibilities as needed.

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

  • Bachelor's degree required, preferably in Engineering, Science (e.g., Chemistry, Biology, Physics), or Math (particularly Statistics).
  • Minimum of 5 years of progressively responsible experience in relevant roles.
  • Experience in an FDA-regulated manufacturing or industrial setting is essential.
  • Proficient understanding of FDA/ISO 13485 Quality System requirements, GxP, and other applicable standards and regulations.
  • Technical proficiency in process validation, statistical methodologies, and risk management is necessary.
  • Previous involvement in quality audits; certification such as Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) is advantageous.
  • Knowledge of Lean manufacturing/Six Sigma principles is beneficial.
  • Effective collaboration skills with a proven ability to coach and mentor others.
  • Self-driven with excellent organizational skills, capable of working independently.
  • Strong written and verbal communication abilities.

What's on Offer

  • Robust 401(k) Retirement program, including a substantial company match.
  • Company-paid life insurance and disability income protection, with optional buy-up.
  • Three weeks of vacation annually, supplemented by additional sick time and floating holidays.
  • Comprehensive medical, dental, and vision plans, featuring tax-advantaged health care and dependent care spending accounts.
  • Access to wellness and mental health support through our Employee Assistance Program (EAP).
  • Participation in our Employee Stock Purchasing Plan.
  • Six weeks of paid parental leave.
  • Tuition support available through our Educational Assistance Program.
  • Voluntary benefits, including group legal, ID theft protection, and university loan refinancing.
  • Many more benefits!

Apply today for immediate consideration of your application! We are looking to start interviews early next week.

Isabel Reynes
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Job summary

Engineering & Manufacturing
Sub Sector
Quality, Technical
Industrial / Manufacturing
Contract Type
Consultant name
Isabel Reynes
Job Reference