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Quality Engineering Manager Medical Device Jobs

CEVIANS LLC

Quality Engineering Manager

Costa Mesa, CA · On-site

The Quality Engineering Manager will support Cevians 3 operating sites quality engineers. Will ... Medical, Dental, Vision, PTO, and Paid Holidays. Benefits are effective on the 1st day of the month ...

Moog

Quality Engineering Manager

Buffalo, NY · On-site

$125K - $175K/yr

Quality Engineering Manager Reporting To: Director, AG Site Operations Work Schedule: Onsite ... Comprehensive insurance coverage including medical, dental, vision, life, disability, Employee ...

Joby Aviation

Quality Engineering, Manager

Marina, CA

$170K - $267K/yr

Reporting to the Senior Quality Engineering Manager, the Quality Engineering Manager has the responsibility for all activities related to the Quality Engineering function within their assigned scope.

Joby Aviation

Quality Engineering, Manager

San Carlos, CA · On-site

$170K - $267K/yr

Reporting to the Senior Quality Engineering Manager, the Quality Engineering Manager has the responsibility for all activities related to the Quality Engineering function within their assigned scope.

Honeywell

Quality Engineering Manager

Boyne City, MI · On-site

Senior Quality Engineering Manager in the aerospace industry typically needs a combination of ... This package includes employer subsidized Medical, Dental, Vision, and Life Insurance; Short-Term ...

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$60K

$111.7K

$158.5K

How much do quality engineering manager medical device jobs pay per year?

As of Sep 10, 2026, the average yearly pay for quality engineering manager medical device in the United States is $111,650.00, according to ZipRecruiter salary data. Most workers in this role earn between $92,000.00 and $131,000.00 per year, depending on experience, location, and employer.

What does a quality engineering manager do in the medical device industry?

A Quality Engineering Manager in the medical device industry oversees the quality assurance and control processes to ensure products meet regulatory standards and customer expectations. They lead teams responsible for implementing quality systems, conducting audits, and resolving quality issues. Their role often includes ensuring compliance with standards such as ISO 13485 and FDA regulations, managing risk assessments, and driving continuous improvement initiatives. They also collaborate with other departments to support product development and manufacturing while maintaining product safety and effectiveness.

What are the key skills and qualifications needed to thrive as a quality engineering manager in the medical device industry?

To thrive as a Quality Engineering Manager in medical devices, you need a strong background in quality assurance, regulatory compliance (like FDA and ISO 13485), and a degree in engineering or a related field. Familiarity with quality management systems (QMS), risk management tools (such as FMEA), and certifications like Six Sigma or ASQ are typically required. Leadership, problem-solving, and effective communication are vital soft skills for managing teams and driving continuous improvement. These competencies ensure product safety, regulatory adherence, and high-quality outcomes critical to patient health and company success.

What are some common challenges faced by a quality engineering manager in the medical device industry, and how can they be addressed?

A Quality Engineering Manager in the medical device field often faces challenges such as navigating complex regulatory requirements, ensuring cross-functional teams adhere to quality standards, and managing product risk throughout the development lifecycle. Staying current with evolving regulations (like FDA and ISO 13485) and fostering a culture of continuous improvement are key to overcoming these hurdles. Effective communication and collaboration with engineering, manufacturing, and regulatory teams help ensure all processes align with compliance and quality objectives, ultimately supporting safe and successful product launches.

What are popular job titles related to Quality Engineering Manager Medical Device jobs?

For Quality Engineering Manager Medical Device jobs, the most frequently searched job titles are:

Infographic showing various Quality Engineering Manager Medical Device job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, and 5% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $111,650 per year, or $53.7 per hour.

Quality Engineering Manager

Allen, TX • On-site

Quest Medical, Inc.
Manufacturing • 51 - 200 employees
Learn more about Quest Medical, Inc.external

Full-time

Re-posted 15 days ago

Job description

JD534-016:
Position:
Manager, Quality Engineering
Department:
Reports To:
Vice President, Quality Assurance & Regulatory Affairs
FLSA Status:
JD Number:
JD534-016
Revision:
A
Summary:
Manages the Quality Engineering team to support new product development, process quality, CAPA, post-market compliance, supplier management, project management, internal & external auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA).
General Duties and Responsibilities:
  • Ensure the ongoing integrity, adequacy, and appropriateness of the Quality Management System and associated processes.
  • Provide technical support, leadership and quality guidance to multi-functional teams, including Quality, Regulatory, R&D, Operations, Engineering, and Marketing.
  • Select, develop, and evaluate Quality Engineering staff to support all aspects of design and manufacturing quality.
  • Act as assistant to the Management Representative during regulatory and customer audits.
  • Develop and implement and improve efficient quality systems processes.
  • Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization.
  • Establish and maintain quality metrics and utilizes KPIs to drive improvements.
  • Manage the CAPA program (to include Complaints, SCARs, NCMRs, Audit Non-Conformances and Corrective & Preventive Action projects). Ensure thorough investigations and implement effective corrective actions to prevent recurring issues.
  • Utilize root cause analysis and statistical techniques for complex problem solving of technical product and manufacturing issues.
  • Ensure a high level of supplier quality through effective supplier evaluation, approval, and monitoring processes. Collaborate with internal supply chain and external suppliers to drive continual improvement of supplier quality.
  • Develop and maintain FMEAs, Controls Plans, and SOPs to identify and mitigate risks.
  • Support the development and validation of new products and production lines.
  • Write, review, and approve documents (SOPs, Protocols, Reports, and ECOs) pertaining to key quality system elements affecting product quality.
  • Apply basic risk management principles to all aspects of the quality system.

Qualifications:
Required
  • Technical Engineering or Science degree at the Bachelor level or above.
  • 8+ years of quality engineering experience in a highly regulated industry.
  • 3+ years managing team members with varied backgrounds, experience, and technical capabilities.
  • Excellent working knowledge of medical device regulations and industry standards pertaining to manufacturing (FDA 21 CFR Part 820, ISO 13485, EU MDR (2017/745), the Medical Device Single Audit Program (MDSAP), and ISO 14971), IEC 60601..
  • Demonstrated project management skills, including the ability to prioritize and manage multiple project workloads in a highly dynamic production environment.
  • Solid working background utilizing quality management methods and tools (CAPA, Root Cause Analysis, FMEA, Control Plans, Statistical Techniques, MSA, etc.)
  • Demonstrated experience using trending and analysis reporting to drive organizational improvements.
  • Ability to develop and deliver clear communications (written and verbal), ensuring timely and relevant communication.
  • Some travel, domestic or international, may be required (up to 25%).

Preferred
  • ASQ Certified Quality Manager or Certified Quality Engineer
  • ISO 13485 Lead Auditor
  • Lean Six Sigma Green Belt or Black Belt
  • Working knowledge of IEC 60601 and IEC 62366
  • Experience with sterile product assembly and packaging
  • Experience with electronics assembly

Approvals:
Employee
Date
Department Head
Date

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