Quality Systems Engineer - Medical Device Manufacturing

Opportunity to be the subject matter expert on all things ISO in the company

Join a growing team with career advancement

About Our Client

Our client, a leading medical device manufacturer, is seeking a Quality Systems Engineer (QMS) to maintain and improve the company's quality management system (QMS) in compliance with ISO 13485, FDA regulations, and other applicable standards. This role ensures robust processes for documentation, audits, and continuous improvement initiatives that support product quality and regulatory compliance. If interested, please read on and apply to the Quality Systems Engineer (QMS) - Medical Device Manufacturing job based near Fall River, MA.

Job Description

The Quality Systems Engineer (QMS) - Medical Device Manufacturing will be responsible for the following;

Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485 and FDA requirements.

Manage internal audits and support external audits from regulatory bodies and customers.

Ensure proper documentation control, including SOPs, work instructions, and quality records.

Collaborate with cross-functional teams to address non-conformances and implement corrective/preventive actions (CAPA).

Monitor and report on quality system performance metrics and drive continuous improvement.

Support risk management activities and ensure compliance with applicable standards.

Provide training and guidance on QMS processes to internal teams.

Assist in new product introduction from a quality systems perspective.

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

The ideal Quality Systems Engineer (QMS) - Medical Device Manufacturing will have the following qualifications:

Bachelor's degree in Engineering, Quality, or related field.

3+ years of experience in quality systems engineering within medical device or regulated manufacturing.

Strong knowledge of ISO 13485, FDA QSR, and related regulatory requirements.

Lead Auditor Certification (ISO 13485 preferred; ISO 9001, AS9100, IATF 16949, and ISO 14001 experience highly desirable).

Experience with internal auditing and CAPA processes.

Excellent organizational and communication skills.

Proficiency in QMS software and Microsoft Office tools.

ASQ Certified Quality Engineer (CQE) or Auditor (CQA) certification.

Familiarity with risk management tools (ISO 14971).

Experience with electronic document control systems.

What's on Offer

The successful Quality Systems Engineer (QMS) - Medical Device Manufacturing will be rewarded with the following:

Competitive salary ranging from $80,000 to $115,000 USD.

Performance-based bonus structure.

Opportunities for professional development and career advancement.

A collaborative and supportive work environment

Comprehensive benefits package to support overall well-being.

Contact

Erin McQuillan

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