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Medical Device Quality Jobs (NOW HIRING)

GlaxoSmithKline

Senior Device Quality Engineer

Zebulon, NC

$75K - $101K/yr

Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices ... Act as site Subject Matter Expert (SME) for device quality processes, providing guidance to ...

Stark Pharma Solutions Inc

Quality Technician

Minneapolis, MN · On-site

$18.75 - $25.25/hr

Minneapolis, MN Duration: Long Term Job Overview We are seeking a Quality Technician with experience in the medical device industry to support quality assurance activities, product investigations ...

Marquee Staffing - OC

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Medical Device Assembler, Weekend Overnight 3/12 Schedule

Irvine, CA · On-site

$19 - $21/hr

Medical Device implant manufacturer in Irvine is seeking applicants with manufacturing experience ... Demonstrate accuracy, thoroughness and monitors own work to ensure quality. * Practice and always ...

Marquee Staffing - OC

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Medical Device Assembler, Weekend Day 3/12 Schedule

Irvine, CA · On-site

$19 - $20/hr

Medical Device implant manufacturer in Irvine is seeking applicants with manufacturing experience ... Demonstrate accuracy, thoroughness and monitors own work to ensure quality. * Practice and always ...

GSK

Senior Device Quality Engineer

Zebulon, NC · On-site

$75K - $101K/yr

Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices ... Act as site Subject Matter Expert (SME) for device quality processes, providing guidance to ...

Flotec

Be Seen First

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based medical device manufacturer specializing in respiratory and oxygen delivery equipment. We manufacture ...

Socket.dev

Senior Device Quality Engineer

San Francisco, CA · On-site

$160 - $180/hr

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery ... As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · Hybrid

$138K - $185K/yr

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality ... This senior-level position requires you to work closely with device development teams, medical ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · On-site

$138K - $185K/yr

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality ... This senior-level position requires you to work closely with device development teams, medical ...

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Ensure work is completed in compliance with company quality system and medical device regulations. Essential Functions Assemble and test finished and semi-finished medical devices per established ...

Heartflow

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 ... As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality ...

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Medical Device Quality information

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$21

$36

$70

How much do medical device quality jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for medical device quality in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What is medical device quality?

Medical Device Quality refers to the processes and standards used to ensure that medical devices are safe, effective, and comply with regulatory requirements throughout their lifecycle. Professionals in this field oversee quality management systems, conduct inspections, manage documentation, and ensure that products meet both company and government standards. Their work helps prevent defects, maintains patient safety, and supports compliance with agencies like the FDA and ISO standards.

What does a medical device quality professional do?

Professionals in Medical Device Quality are typically responsible for ensuring that products meet regulatory standards and company quality requirements. Daily tasks often include reviewing and updating quality documentation, conducting audits, analyzing data from quality tests, and collaborating with manufacturing and engineering teams to resolve any issues. They also play a key role in managing non-conformances, implementing corrective actions, and supporting continuous improvement initiatives. Regular communication with regulatory bodies and staying updated on compliance requirements are also common aspects of the role.

What are the key skills and qualifications needed to thrive as a medical device quality professional?

To thrive as a Medical Device Quality professional, you need expertise in quality assurance, regulatory compliance (such as FDA and ISO 13485), and strong analytical skills, typically backed by a degree in engineering or a related field. Familiarity with quality management systems (QMS), risk management tools, and validation processes is essential, as are certifications like ASQ CQE or Six Sigma. Attention to detail, problem-solving, and effective communication are critical soft skills for ensuring product safety and collaborating across teams. These competencies help ensure that medical devices meet stringent regulatory standards and maintain patient safety and company reputation.

What is the difference between Medical Device Quality vs Medical Device Regulatory Affairs?

AspectMedical Device QualityMedical Device Regulatory Affairs
CertificationsISO 13485, Six Sigma, CQERegulatory affairs certifications, RAC, ISO 13485 familiarity
Work EnvironmentQuality departments, manufacturing sites, labsRegulatory agencies, corporate offices, compliance teams
Industry UsageEnsures product quality, compliance with standardsManages regulatory submissions, compliance with laws

Medical Device Quality focuses on maintaining product standards and compliance through quality management systems, while Medical Device Regulatory Affairs handles regulatory submissions and ensures products meet legal requirements. Both roles are essential in bringing safe, compliant medical devices to market, but they emphasize different aspects of the product lifecycle.

More about Medical Device Quality jobs

What cities are hiring for Medical Device Quality jobs?

Cities with the most Medical Device Quality job openings:

What states have the most Medical Device Quality jobs?

States with the most job openings for Medical Device Quality jobs include:

Medical Device Quality jobs near you
Infographic showing various Medical Device Quality job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Medical Device Quality Engineer at Blue Ash, OH

Volto USA

Blue Ash, OH • On-site

$66K - $85K/yr

Contractor

Re-posted 4 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: