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Quality Engineering Manager Medical Device Jobs

Resonetics

Quality Manager

Nashua, NH · On-site

$96K - $142K/yr

The Quality Manager provides customer- and factory-facing quality support for contract ... Required Qualifications * 8+ years' experience in a Quality Engineering role for a medical device ...

Resonetics

Quality Manager

Nashua, NH · On-site

The Quality Manager provides customer- and factory-facing quality support for contract ... Required Qualifications * 8+ years' experience in a Quality Engineering role for a medical device ...

Socket.dev

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery ... Partner with engineering teams to execute "Compliance at Speed," ensuring Agile sprints meet all ...

Resonetics

Quality Engineering Technician

Hudson, WI

$21 - $30/hr

... medical device industry. With rapid expansion across all our locations, we continue to push the ... Managing the flow of finished goods to shipping * Coordinating timely processing of Nonconformances ...

RXinsider LTD.

$65K - $87K/yr

... Medical Device Management ("MDM") Team in the area of physician preference items. Objective is to ... quality, and outcomes. HCA Healthcare has been recognized as one of the World's Most Ethical ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

... engineering drawings, work instructions, and quality standards * Inspect finished assemblies for ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

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 ...

Nihon Kohden OrangeMed, LLC

$76K - $105K/yr

... quality engineering solutions in a regulated medical device environment. Duties and Responsibilities * Lead, manage, and develop a team of mechanical engineers and technicians responsible for the ...

BioTalent

Manufacturing Engineering Manager

Irvine, CA · On-site

$165K - $175K/yr

Partner cross-functionally with Quality, Engineering, and Operations to resolve production and ... Experience in a regulated manufacturing environment; medical device experience preferred * Proven ...

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Quality Engineering Manager Medical Device information

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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.

Medical Device Quality Engineer at Blue Ash, OH

Blue Ash, OH • On-site

Volto USA
See more jobs at Volto USAexternal

$66K - $85K/yr

Contractor

Re-posted 11 days ago

Job description

Role: Medical Device Quality Engineer 
Location: Blue Ash, OH
Duration: 6 months
Role Descriptions: · 7+ years of engineering experience in medical device or other regulated industries. · Experience leading cross-functional technical projects. ·
Experience with component development, supplier qualification, design verification, and manufacturing validation. · Strong understanding of design controls, change management, risk management, process validation, and quality system compliance.
Must Have Technical/Functional Skills
· Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, and Engineering Change Management (ECO/ECN/ECR).
· Hands-on experience with Design Verification & Validation (V&V), test methods, protocol development, and technical documentation.
· Deep understanding of Risk Management methodologies, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
· Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory compliance requirements.
· Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM). · Proficiency in Process Validation activities including IQ/OQ/PQ, pilot builds, validation builds, and manufacturing transfer. · Ability to interpret engineering drawings, GD&T, tolerance stack-ups, specifications, and acceptance criteria. · Strong root cause analysis and problem-solving skills utilizing 8D, CAPA, 5 Why, Fishbone, and corrective action processes. · Excellent project management skills, including planning, scheduling, risk management, stakeholder management, and cross-functional coordination. · Effective leadership, communication, and influencing skills, with the ability to drive decisions and deliver results without direct authority.
Roles & Responsibilities
· Lead multiple high-priority lifecycle change projects from concept through implementation.
· Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
· Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
· Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
· Support design verification and validation activities, including test planning, execution, data review, and  technical documentation.
· Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
· Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
· Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
· Drive root cause analysis, technical problem solving, and timely closure of project issues.
· Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
· Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.
Generic Managerial Skills, If any
· Strong communication skills, with proficiency in reading, writing, and speaking English.
· Ability to multitask, understand customer requirements, and respond promptly and accurately.
· Capability to prioritize and manage multiple tasks in a fast‑paced environment.
· Ability to understand and follow complex written procedures.
· Ability to work effectively in a team environment and contribute to team goals.
· Strong decision‑making and problem‑solving abilities with sound situational judgment.
Essential Skills: EIS : MDD Risk Management
Desirable Skills: