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Quality Engineer - Medical Device - Shirley, MA

Ayer, Massachusetts Permanent USD95,000 - USD105,000 per year View Job Description
The Quality Engineer will support quality validation, product qualification, risk management, and quality systems activities across the full product life cycle, ensuring compliance with regulatory requirements and ISO standards. This position partners with engineering, manufacturing, R&D, supply chain, and quality teams to drive product quality, validation, continuous improvement, and successful new product introductions.
  • Join a growing medical manufacturing leader shaping quality excellence
  • Strong benefits package featuring 16 weeks paid parental leave

About Our Client

Our client is a globally recognized manufacturing organization known for innovation, operational excellence, and a strong commitment to quality. As part of a larger international group, the company offers outstanding career development opportunities, collaborative teams, and an inclusive culture focused on employee growth and well being.

Job Description

  • Develop, implement, and maintain Quality Management System (QMS) processes, procedures, templates, and controlled documentation.
  • Support New Product Introduction (NPI) programs by ensuring all quality requirements and deliverables are completed efficiently and compliantly.
  • Partner with validation experts to oversee product and process verification and validation activities.
  • Lead investigations into quality events, product nonconformances, process deviations, and customer complaints.
  • Drive robust CAPA activities using structured root cause methodologies including 5 Whys, Fishbone Analysis, and FMEA.
  • Evaluate and support product, process, and design changes through comprehensive risk and impact assessments.
  • Collaborate with cross-functional teams to identify and implement process and product quality improvements.
  • Support validation protocol development, execution, and life cycle documentation maintenance.
  • Participate in internal audits and generate findings that support compliance and continuous improvement.
  • Deliver training and guidance on quality tools, systems, and best practices.
  • Champion a culture of quality, compliance, risk awareness, and continuous improvement throughout the organization.

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.

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 in Engineering or a related scientific discipline.
  • 2-3+ years of Quality Engineering or Quality Assurance experience within a regulated environment.
  • Strong knowledge of ISO 13485 and/or ISO 9001 standards.
  • Experience supporting product and process validation activities.
  • Understanding of design control and product development lifecycles.
  • Internal auditing experience; Lead Auditor certification is a plus.
  • Proven success driving continuous improvement initiatives and Lean methodologies.
  • Strong root cause analysis and CAPA management experience.
  • Excellent communication, project management, and stakeholder engagement skills.
  • Ability to thrive in a fast-paced, evolving manufacturing environment.

What's on Offer

  • Industry-leading parental leave and family planning benefits.
  • Strong 401(k) program with employer contributions and matching.
  • Opportunity to work on innovative products in a highly regulated environment.
  • Exposure to cross-functional projects and new product development initiatives.
  • Inclusive culture with significant investment in employee growth, wellbeing, and career progression.
Contact
Taylor Rankin
Quote job ref
JN-102026-7120734

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Where
Ayer
Contract Type
Permanent
Consultant name
Taylor Rankin
Job Reference
JN-102026-7120734
 

Michael Page is an inclusive employer. We want to make sure you have everything you need to perform at your best throughout our hiring process, so please let us know if there is anything we can do to support with your application or interview.