Quality Systems Specialist

Job Description

Job Description

At MPE, we're dedicated to making a difference in the world through cutting-edge medical technology. Our mission is to be the global leader in design, engineering, and manufacturing solutions for the medical and technology industries — creating impactful solutions that improve lives, and fostering an environment where our team members can thrive, grow, and contribute to groundbreaking advancements in the medical field.

A better career for you. Creating medical technology for all.

Why This Role

Every great medical device company runs on a strong Quality Management System behind the scenes — and that's where you come in. As our Quality Systems Specialist, you'll help keep MPE's QMS complete, controlled, and always inspection-ready, working closely with Quality leadership and process owners across the company. You'll also own our internal audit program — a real chance to lead something end-to-end early in your career, not just support it.

You'll get broad exposure across the quality function — document control, training compliance, internal audits, CAPA tracking, and audit readiness — making this a great foundation for anyone building a long-term career in Quality or Regulatory Affairs within medical device manufacturing.

What You'll Do

Document Control & Training

• Support document change requests, routing, approvals, revision control, release, and archival
• Support training assignments tied to new or revised documents, and follow up on overdue training

Internal Audits & CAPA

• Lead the internal audit program, including checklist preparation, evidence gathering, audit notes, findings, and follow-up
• Track audit findings, CAPA actions, complaint actions, and other QMS commitments through to closure

Audit & Inspection Readiness

• Help prepare for customer audits, ISO audits, and regulatory inspections by organizing objective evidence and records
• Identify incomplete records, overdue actions, repeat issues, or potential compliance gaps, and escalate as needed

Metrics & Reporting

• Maintain QMS logs, trackers, metrics, and dashboards
• Support preparation of management review inputs and quality system performance data

Cross-Functional Collaboration

• Partner with Operations, Engineering, Customer Service, HR, IT, and other departments to support QMS execution

What You Bring

Required

• Bachelor's degree in a scientific, engineering, or business administration discipline, or equivalent combination of education/experience
• 2+ years of experience in a Quality or Regulatory Affairs role within a GMP-related industry

Nice to Have

• Working knowledge of quality system standards (QSR/ISO 13485)

Why Work With MPE?

• Medical, dental, vision, short- and long-term disability, and life insurance starting the first of the month after your hire date
• 401(k) match and profit sharing
• Vacation time from day one
• 9 paid holidays for regular full-time employees
• Paid training

Physical and mental demands

• Frequent – Seeing, reading, hearing, sitting, listening, decision making, comprehension, computer use, writing, and collaborating
• Intermittent – measuring, math, presenting, and lifting up to 40 lbs

The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Work Environment

Standard office environment. Will require going into production areas which may be hot, cool, dusty, and have a moderate noise level.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position .