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Quality Engineer Medical Devices Jobs (NOW HIRING)

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Quality Engineer: Medical Devices

San Francisco, CA · On-site

$84K - $109K/yr

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment ...

Collate

Quality Engineer: Medical Devices

San Francisco, CA · On-site

$84K - $109K/yr

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment ...

Hemostasis, LLC

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Chemical Engineer - Medical Devices

White Bear Lake, MN · On-site

$90K - $120K/yr

Chemical Engineer - Medical Devices Hemostasis, LLC designs, develops, manufactures, and markets ... Collaborate closely with R&D, Quality, Manufacturing, and business leadership Qualifications

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Quality Engineer Medical Devices information

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$45K

$84K

$119K

How much do quality engineer medical devices jobs pay per year?

As of Jun 13, 2026, the average yearly pay for quality engineer medical devices in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

What does a Quality Engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory standards and quality requirements throughout their lifecycle. They develop and implement quality control processes, conduct risk assessments, lead investigations into product defects, and work closely with cross-functional teams to ensure compliance with regulations such as FDA and ISO 13485. Their work helps to guarantee the safety, reliability, and effectiveness of medical devices before they reach patients.

How does a Quality Engineer collaborate with cross-functional teams in the medical device industry?

Quality Engineers in the medical device field work closely with design, manufacturing, and regulatory teams to ensure products meet stringent quality and compliance standards. They participate in design reviews, help develop verification and validation protocols, and support the implementation of corrective actions. Regular communication with production and R&D teams is essential to identify potential risks early and to ensure that quality is built into every stage of product development. This collaborative approach not only improves product safety and efficacy but also streamlines regulatory submissions and audits.

What is the difference between Quality Engineer Medical Devices vs Quality Technician Medical Devices?

AspectQuality Engineer Medical DevicesQuality Technician Medical Devices
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, basic quality certifications
ResponsibilitiesDesigning quality systems, process improvements, root cause analysisInspecting products, conducting tests, recording quality data
Work EnvironmentDesign and development labs, manufacturing plantsManufacturing floors, quality control labs
Employer & Industry UsageMedical device companies, OEMs, suppliersManufacturers, contract labs, quality departments

In summary, Quality Engineer Medical Devices focus on developing quality systems, process improvements, and ensuring compliance, while Quality Technicians primarily perform product inspections and testing. Both roles are essential in maintaining high standards in the medical device industry but differ in scope and responsibilities.

What are the key skills and qualifications needed to thrive as a Quality Engineer in Medical Devices, and why are they important?

To thrive as a Quality Engineer in Medical Devices, you typically need a degree in engineering or a related field, combined with knowledge of quality assurance principles and regulatory requirements (such as ISO 13485 and FDA regulations). Familiarity with risk management tools, validation protocols, and quality management systems (QMS), as well as certifications like CQE (Certified Quality Engineer), are highly valuable. Strong analytical thinking, attention to detail, and effective communication skills enable you to identify issues, collaborate with cross-functional teams, and ensure compliance. These competencies are crucial for maintaining product safety, meeting regulatory standards, and supporting a culture of continuous improvement in the medical device industry.
More about Quality Engineer Medical Devices jobs
What cities are hiring for Quality Engineer Medical Devices jobs? Cities with the most Quality Engineer Medical Devices job openings:
What states have the most Quality Engineer Medical Devices jobs? States with the most job openings for Quality Engineer Medical Devices jobs include:
What job categories do people searching Quality Engineer Medical Devices jobs look for? The top searched job categories for Quality Engineer Medical Devices jobs are:
Quality Engineer Medical Devices jobs near you
Infographic showing various Quality Engineer Medical Devices job openings in the United States as of June 2026, with employment types broken down into 80% Full Time, 12% Part Time, and 8% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Senior Quality Engineer - Medical Devices

Stark Pharma Solutions Inc

Arden Hills, MN • On-site

$92K - $125K/yr

Contractor

Posted 8 days ago

Job description

Job Title: Senior Quality Engineer – Medical Devices

Location: Arden Hills, MN - Onsite

Job Summary:

We are seeking a Senior Quality Engineer with strong experience in combination products, particularly drug-coated medical devices. This role focuses on enhancing manufacturing processes, ensuring product quality, and maintaining compliance with regulatory standards.

The ideal candidate will bring deep expertise in quality systems, process validation, and regulatory compliance, along with hands-on experience supporting products from development through commercialization.

Key Responsibilities

  • Review and approve change requests related to product, process, validation, and verification documentation
  • Develop and maintain quality documentation including SOPs, quality plans, and inspection procedures
  • Ensure compliance with FDA, ISO, and regulatory requirements, including 21 CFR Part 211 and/or Part 4
  • Represent Quality in design reviews and cross-functional project discussions
  • Perform gap analyses and ensure alignment of product requirements and verification documentation
  • Review and approve validation activities including:
    • Process Qualifications (IQ/OQ/PQ)
    • Test Method Validations
    • Gage R&R and Process Capability Studies
    • Design of Experiments (DOE) and FMEAs
  • Support CAPA, NCR, and complaint investigations, including root cause analysis and effectiveness checks
  • Lead and support inspection and acceptance activities (FAI, in-process inspections, sampling plans)
  • Apply statistical tools and methodologies (SPC, DOE, ANOVA) to drive quality improvements
  • Collaborate with cross-functional teams to resolve quality issues and improve processes

Required Qualifications

  • Bachelor’s degree in Engineering or related field
  • 6–8+ years of experience in Quality or Design Quality Engineering within medical devices
  • Hands-on experience with combination products (drug-coated devices strongly preferred)
  • Strong knowledge of 21 CFR Part 211 and/or Part 4
  • Experience with process validation (IQ/OQ/PQ) and quality tools (SPC, DOE, FMEA, GR&R, CAPA)
  • Solid understanding of FDA regulations and ISO standards (ISO 13485, 14971, 11607)
  • Experience with CAPA ownership and quality event systems (e.g., NCEP)
  • Strong analytical, problem-solving, and communication skills