Senior Quality Engineer - Medical Device - Billerica, MA

Bedford, Massachusetts Permanent USD80,000 - USD120,000 per year
  • Stock options and restricted stock units for employees
  • 20 percent increase in sales last quarter

About Our Client

Our client stands at the forefront of innovation, specializing in the development, manufacturing, and distribution of devices, implants, and services tailored for the treatment of peripheral vascular disease. With a global presence, our client maintains a unique culture reminiscent of a small company, fostering collaboration, teamwork, and decentralized decision-making. This approach allows the organization to swiftly respond to the evolving needs of vascular surgeons and their patients without being hindered by layers of bureaucracy.

Driven by a commitment to continuous innovation, our client honors its founder's legacy by relentlessly pursuing advancements in vascular surgery devices. Through strategic acquisitions and a focus on innovation, our client has expanded its product portfolio to cater to a diverse range of surgical needs. With a dedicated sales force operating in multiple countries, our client ensures that its cutting-edge products directly reach vascular surgeons, empowering them to achieve consistently positive outcomes for their patients. Looking ahead, our client remains steadfast in its vision to further diversify its offerings, providing comprehensive solutions for both open vascular surgery and minimally invasive procedures to meet the challenges of the future.

Job Description

  • Executes day-to-day activities aligned with quality objectives and corporate policies for building high-quality medical devices.
  • Conducts audits of the Quality Management System (QMS) and collaborates with external agencies to facilitate internal audits.
  • Prepares for and leads external audits, including MDD, MDR, ISO13485, MDSAP, and UKCA.
  • Updates the quality system based on non-conformities identified during internal and external audits.
  • Leads and implements compliance and process improvements within Manufacturing and Quality Systems.
  • Identifies root causes and implements corrective and preventive actions based on internal audit findings.
  • Develops and maintains a trace matrix for new standards impacting the QMS.
  • Analyzes and reports on quality system metrics.

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 (B.A.) from a four-year college or university, preferably in Science or Engineering.
  • Minimum of six years of experience in the medical device industry.

What's on Offer

  • Competitive compensation package
  • Stock options and restricted stock units available for eligible employees
  • 401(k) plan with employer matching
  • Comprehensive medical, dental, and vision coverage
  • Flexible spending account options for medical and dependent care expenses
  • Life, short-term, and long-term disability insurance options
  • Discount programs for car and homeowner insurance
  • Access to an Employee Assistance Program (EAP)
  • Generous paid vacation, personal, and sick time
  • Paid major holidays
  • Convenient location in Burlington, MA, within walking distance to shops and restaurants
Isabel Reynes
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Job summary

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