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Senior Quality Engineer Medical Device Jobs (NOW HIRING)

kindeva

Senior Quality Engineer

Northridge, CA

$95K - $129K/yr

The Senior Quality Engineer will be able to effectively assist in troubleshooting issues related to ... Minimum 5 years' experience within the pharmaceutical or medical device industry. * Ability to work ...

kindeva

Senior Quality Engineer

Northridge, CA · On-site

$95K - $129K/yr

The Senior Quality Engineer will be able to effectively assist in troubleshooting issues related to ... Minimum 5 years' experience within the pharmaceutical or medical device industry. * Ability to work ...

kindeva

Senior Quality Engineer

Northridge, CA

$95K - $129K/yr

The Senior Quality Engineer will be able to effectively assist in troubleshooting issues related to ... Minimum 5 years' experience within the pharmaceutical or medical device industry. * Ability to work ...

kindeva

Senior Quality Engineer

Northridge, CA · On-site

$95K - $129K/yr

The Senior Quality Engineer will be able to effectively assist in troubleshooting issues related to ... Minimum 5 years' experience within the pharmaceutical or medical device industry. * Ability to work ...

Advita Ortho

Sr. Quality Engineer

Gainesville, FL · On-site

$79K - $108K/yr

Sr. Quality Engineer Department: Quality Employment Type: Full Time Location: Gainesville, FL ... medical device or highly regulated industry * Demonstrated experience supporting full product ...

Ametek

Senior Quality Engineer

Jackson, MN

$83K - $113K/yr

The Senior Quality Engineer is responsible to ensure the operations adherence to organization ... Prior medical device experience. Preferably Class II or III medical device. * Experience in ...

Critical Innovations

Senior Quality Engineer I

Lawndale, CA · On-site

$90K - $123K/yr

The Senior Quality Engineer's responsibilities fall under four main areas: * Management ... Strong understanding of quality management systems and regulatory requirements in medical device ...

Pacer Group

Senior Quality Engineer

Sturtevant, WI · On-site

$50 - $52/hr

Senior Quality Engineer Job Location: Sturtevant, WI 53177 Job Duration: 6 months Job Summary ... Knowledge of quality requirements for medical device / pharmaceutical organization. * Strong ...

Pacer Group

Senior Quality Engineer

Sturtevant, WI · On-site

$50 - $52/hr

Senior Quality Engineer Job Location: Sturtevant, WI 53177 Job Duration: 6 months Job Summary ... Knowledge of quality requirements for medical device / pharmaceutical organization. * Strong ...

Tactile Medical

Senior Quality Engineer

Minneapolis, MN · On-site

$92K - $125K/yr

The Senior Quality Engineer provides quality engineering leadership for manufacturing and ... medical device industry * Bachelor level degree in Engineering (Mechanical, Material Science or ...

Highridge Medical

Sr Quality Engineer

Westminster, CO

$89K - $121K/yr

Sr Quality Engineer Principal Duties and Responsibilities: Serves as the design quality ... EU medical device regulations, design assurance, risk analysis techniques, and product testing ...

Highridge Medical

Sr Quality Engineer

Westminster, CO · On-site

$89K - $121K/yr

Sr Quality Engineer Principal Duties and Responsibilities: • Serves as the design quality ... EU medical device regulations, design assurance, risk analysis techniques, and product testing ...

Glaukos

Sr. Quality Engineer II

San Clemente, CA · On-site

$93K - $126K/yr

We're seeking a Sr. Quality Engineer II or Sr. Quality Specialist II to support the manufacturing and continuous improvement of our innovative combination products (pharmaceutical and medical device)

Glaukos

Sr. Quality Engineer II

San Clemente, CA

$93K - $126K/yr

We're seeking a Sr. Quality Engineer II or Sr. Quality Specialist II to support the manufacturing and continuous improvement of our innovative combination products (pharmaceutical and medical device)

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All JobsSenior Quality Engineer Medical Device Jobs

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 Jun 11, 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 are Senior Quality Engineers in the medical device industry?

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 in Medical Devices, 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 in the medical device industry 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

Quality Engineer - Danvers, MA

Fusion Life Sciences

Danvers, MA • On-site

$76K - $98K/yr

Contractor

Posted 16 days ago

Job description

Position: Sr Quality Engineer
Location: Danvers, MA (100% on-site)
Duration of project: 12 months +

Requirements:

  • Medical Device Design & Development
  • Risk Management: dFMEA, pFMEA, Statistical analysis
  • Technical Writing: IQs, PQs, TMVs
  • Hands on experience on upstream new product development vs downstream manufacturing transfer and operations quality
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016
  • Demonstrated working knowledge of process validation, statistical methods, risk management
  • Green Belt Six Sigma/DRM Training/Certification is preferred, but not required
  • ASQ-CQE, CQA, CBA or equivalent certifications preferred, but not required
  • SAP QM or SPC Software experience preferred, but not required

Education Required:

  • Bachelor’s Degree in Engineering, Science or technical field AND 5-7 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality
  • In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.

 Responsibilities Include:

  • Provide Quality Engineering support for commercial medical device products.
  • Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
  • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
  • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
  • Able to present quality during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation
    Present technical data to groups within and outside the organization.
  • Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.