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Senior Medical Device Quality Engineer

SysMind, LLCSalt Lake City, UT🇺🇸United States

Why this role stands out

This hybrid role offers a fantastic opportunity to leverage your extensive medical device quality engineering expertise, contributing to critical manufacturing processes and continuous improvement within a reputable company. You will thrive here if you possess a strong background in CAPA, PFMEA, and FDA/ISO 13485 compliance, allowing you to make a significant impact. Apply now to advance your career in a dynamic healthcare environment.

Quick overview

SeniorityMid Senior
Work modeHybrid
LocationSalt Lake City, UT, United States

Job description

Location: Salt Lake City, UT 84116
Work Arrangement: Hybrid
Contract Duration: 6 Months
Experience: 6–12 Years

Job Overview

We are seeking a Senior Medical Device Quality Engineer with strong experience in regulated manufacturing environments to support quality engineering, manufacturing processes, root cause investigations, and continuous improvement initiatives.

The ideal candidate will have hands-on experience in medical device quality engineering, manufacturing quality, CAPA, process capability, PFMEA, control plans, plastics manufacturing, injection molding, assembly, and labeling processes.

This is a senior-level role requiring the ability to work independently with Quality, Manufacturing, and Operations teams while ensuring compliance with FDA and ISO 13485 requirements.

Primary Skills

  • Medical Device Quality Engineering,
  • Manufacturing Quality,
  • Root Cause Analysis,
  • CAPA,
  • FDA-Regulated Manufacturing,
  • ISO 13485
  • SPC / Statistical Process Control
  • Process Capability Analysis
  • PFMEA
  • Control Plans

Secondary Skills

  • Plastics Manufacturing,
  • Injection Molding,
  • Assembly Processes,
  • Labeling Processes,
  • Quality Improvement,
  • Manufacturing Process Validation
  • Quality Risk Management
  • Nonconformance Management
  • Corrective & Preventive Actions
  • Continuous Improvement
  • Cross-Functional Collaboration

Key Responsibilities

  • Provide senior-level quality engineering support for medical device manufacturing operations.
  • Partner independently with Quality, Manufacturing, Engineering, and Operations teams to identify and resolve quality issues.
  • Lead root cause analysis for manufacturing and product-quality problems.
  • Develop, implement, and monitor CAPA activities through effective resolution and verification.
  • Apply SPC techniques and process capability analysis to evaluate manufacturing process performance.
  • Develop and maintain PFMEAs and Control Plans to identify and mitigate manufacturing risks.
  • Support quality activities associated with plastics manufacturing and injection molding processes.
  • Evaluate and improve assembly and labeling processes to ensure consistent product quality.
  • Investigate nonconformances, process deviations, and recurring manufacturing issues.
  • Analyze manufacturing data and quality metrics to identify trends and opportunities for improvement.
  • Ensure manufacturing processes and quality systems comply with applicable FDA and ISO 13485 requirements.
  • Support audits, inspections, quality investigations, and regulatory compliance activities as required.
  • Collaborate with cross-functional teams to implement sustainable corrective actions and process improvements.
  • Document technical findings, investigations, risk assessments, and quality improvements.
  • Provide technical guidance and recommendations to manufacturing and operations stakeholders.

Required Qualifications

  • 6–12 years of professional experience in quality engineering, manufacturing quality, or a closely related field.
  • Strong experience in medical device manufacturing.
  • Hands-on experience with Medical Device Quality Engineering.
  • Strong knowledge of manufacturing quality processes and quality systems.
  • Proven experience conducting Root Cause Analysis and CAPA.
  • Strong understanding of SPC and process capability analysis.
  • Experience developing and maintaining PFMEAs and Control Plans.
  • Hands-on experience with plastics manufacturing and injection molding.
  • Experience with assembly and labeling processes.
  • Strong understanding of FDA and ISO 13485-regulated manufacturing environments.
  • Ability to work independently with Quality, Manufacturing, and Operations teams.
  • Strong analytical, problem-solving, documentation, and communication skills.

Preferred Experience

  • Experience supporting production-scale medical device manufacturing.
  • Experience with manufacturing process improvement and quality optimization.
  • Experience investigating recurring manufacturing defects and process variation.
  • Knowledge of risk-management methodologies within regulated medical device environments.
  • Experience working with cross-functional engineering and operations teams.
  • Experience supporting regulatory or quality-system audits.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
We are committed to providing reasonable accommodations to qualified applicants with disabilities and for sincerely held religious beliefs, as required by applicable law. Applicants who require a reasonable accommodation during the hiring process may request assistance.
Employment may be contingent upon the successful completion of job-related pre-employment screening, which may include background and reference checks and, where permitted by applicable law and applicable to the position, drug testing. All such screening will be conducted in accordance with applicable federal, state, and local laws.

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