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Senior Quality Engineer Medical Device Jobs (NOW HIRING)

IT MINDS L.L.C.

Quality Engineer - Medical Device

Newark, DE · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Location: Delaware Largescale Medical Device client facing a remediation project here on site in Delaware. What is the project the contractor will be working on?

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is ... medical device experience preferred) Skills & Competencies: * Strong communication, coaching ...

Gentherm

Senior Quality Engineer

Cincinnati, OH · On-site

$85K - $115K/yr

JOB TITLE Senior Quality Engineer ESSENTIAL FUNCTIONS AND RESPONSIBILITIES Senior Quality Engineer for Cincinnati, OH medical device manufacturer to maintain and improve Quality Management System to ...

Cypress HCM

Senior Quality Engineer

New Hope, MN · On-site

$91K - $124K/yr

This Sr Quality Engineer is primarily responsible for providing technical support to ensure ... Previous experience with Class II or Class III medical device contract manufacturing complex ...

Enovis

Sr. Quality Engineer

Austin, TX · On-site

$87K - $118K/yr

Job Title: Sr. Quality Engineer Location: Austin, Texas Job Title/High Level Position Summary ... Knowledge and experience with software as a medical device. * Independently plan, develop, maintain ...

Enovis

Sr. Quality Engineer

Austin, TX · On-site

$87K - $118K/yr

Job Title: Sr. Quality Engineer Location: Austin, Texas Job Title/High Level Position Summary ... Knowledge and experience with software as a medical device. * Independently plan, develop,maintain ...

Noctrix Health

Senior Quality Engineer

Pleasanton, CA

$98K - $133K/yr

Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... The Senior Quality Engineer will work closely with Regulatory Affairs, Clinical Affairs ...

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Senior Quality Engineer Medical Device information

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$60.5K

$105.3K

$146.5K

How much do senior quality engineer medical device jobs pay per year?

As of Aug 14, 2026, the average yearly pay for senior quality engineer medical device in the United States is $105,293.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,500.00 and $120,000.00 per year, depending on experience, location, and employer.

What is a senior quality engineer medical device?

Senior Quality Engineers in the medical device industry are professionals responsible for ensuring that medical devices meet regulatory standards and quality requirements throughout their lifecycle. They lead quality assurance activities, develop and implement testing protocols, coordinate with design and manufacturing teams, and help ensure compliance with relevant regulations such as FDA and ISO standards. Their expertise ensures that products are safe, effective, and reliable for patient use. They also mentor junior engineers and may play a key role in audits and process improvements.

What is the difference between Senior Quality Engineer Medical Device vs Quality Engineer Medical Device?

AspectSenior Quality Engineer Medical DeviceQuality Engineer Medical Device
ResponsibilitiesLead quality initiatives, oversee audits, mentor team membersAssist in quality processes, support audits, perform inspections
Experience & CertificationsTypically 5+ years, often ISO 13485, FDA regulationsEntry to mid-level, basic knowledge of industry standards
Work EnvironmentLeadership roles, cross-functional teams, strategic planningOperational tasks, documentation, compliance support
Usage & IndustryCommonly used in manufacturing, R&D, and quality departmentsUsed across similar settings, often as a stepping stone role

The main difference between a Senior Quality Engineer Medical Device and a Quality Engineer Medical Device lies in experience, responsibilities, and leadership scope. Senior roles involve strategic oversight and mentorship, while standard Quality Engineers focus on supporting quality processes and compliance tasks.

What are the key skills and qualifications needed to thrive as a senior quality engineer medical device, and why are they important?

To excel as a Senior Quality Engineer in Medical Devices, you need a solid background in engineering, quality assurance, and regulatory compliance, typically with a relevant degree and experience in the medical device industry. Familiarity with ISO 13485, FDA 21 CFR Part 820, risk management tools (such as FMEA), and quality management systems is crucial, and certifications like CQE or Six Sigma are often preferred. Strong problem-solving, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure product safety, regulatory compliance, and the continuous improvement of processes critical to patient outcomes and company success.

How does a senior quality engineer medical device typically collaborate with cross-functional teams during product development?

As a Senior Quality Engineer in the medical device sector, you will work closely with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain. Your role involves ensuring quality standards are integrated throughout the product lifecycle, from design reviews and risk assessments to process validation and compliance documentation. Regular meetings, joint problem-solving sessions, and clear communication are vital to resolve issues efficiently and maintain regulatory compliance. This collaborative environment helps to ensure both product safety and timely market release.
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Senior Quality Engineer Medical Device jobs near you
Infographic showing various Senior Quality Engineer Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $105,293 per year, or $50.6 per hour.

Senior Quality Engineer Medical Device

Grove Technical Resources

California City, CA • On-site

$108K - $147K/yr

Other

Posted 2 days ago

New

Job description

Sr Quality Engineer – Medical device Location: Irvine, CA ( Fully Onsite) Duration: 12 Months Work Schedule: Fully Onsite – 5 Days/Week Position Summary The Sr Quality Engineer will support manufacturing quality and compliance for Medtronic Neurovascular products, including embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guidewires. This role will focus on process quality, validation, risk management, CAPA, nonconformance investigations, statistical analysis, and continuous improvement within a regulated medical device manufacturing environment. Key Responsibilities Develop, implement, and maintain quality standards and procedures for manufacturing processes and finished products. Partner with Manufacturing, Process Engineering, R&D, and Regulatory teams to resolve quality and process issues. Conduct inspections, testing, process evaluations, and statistical analysis to ensure product and process requirements are met. Troubleshoot manufacturing and equipment issues and drive effective technical resolutions. Lead root cause investigations using tools such as 5 Whys, 6M, Ishikawa, and Pareto analysis. Manage CAPA and NCMR investigations and implement corrective and preventive actions. Perform risk assessments using FMECA, DFMECA, and PFMECA methodologies. Develop and execute process validation and verification activities, including IQ, OQ, and PQ. Support Test Method Validation (TMV) and related documentation. Apply statistical process control, process capability, measurement system analysis, and tolerance interval techniques using Minitab. Support lean manufacturing and Six Sigma initiatives to improve process efficiency and product quality. Ensure manufacturing documentation, specifications, procedures, and sampling plans comply with applicable requirements. Provide technical guidance, training, and mentorship to junior quality engineers and technicians. Required Qualifications Bachelor’s degree in Engineering, Science, or a related technical field. 4+ years of relevant quality engineering experience; advanced degree with 2+ years may be considered. Medical device manufacturing experience strongly preferred. Minimum 2 years of experience with:FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP FMECA, DFMECA, PFMECA, and risk management Process Verification & Validation (IQ/OQ/PQ) Test Method Development and Validation (TMV) Root Cause Analysis and quality tools Six Sigma and Lean Manufacturing CAPA and NCMR investigations Minitab, statistical analysis, process capability, and MSA Manufacturing quality documentation, specifications, procedures, and sampling methods Preferred Experience Experience with vascular or neurovascular medical devices such as stents, catheters, embolic coils, guidewires, balloons, or aspiration devices. Strong understanding of manufacturing processes and process controls. Experience working in a highly regulated medical device environment. Ability to work independently, manage complex quality issues, and influence cross-functional teams.

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