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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 and identifying potential ...

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 and identifying potential ...

Gilero

$100 - $140/hr

Senior Design Quality Engineer - Medical Devices - Chicago, IL FullTime Chicago, IL, US Salary Range: $100,000.00 To $140,000.00 Annually Are you passionate about using cutting-edge technology to ...

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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 Sep 6, 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 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.

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.

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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 August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Manufacturing Quality Engineer - Medical Devices (3+ yrs exp. req.)

#twiceasnice Recruiting

Waterbury, CT • On-site

$90K - $110K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Job description

Manufacturing Quality Engineer - Medical Devices (3+ yrs exp. req.)
Location: Near Waterbury, CT
Salary: $90,000-$110,000 + Annual Bonus Potential + Benefits
Benefits: Medical, Dental, Vision, 401(k) w/match, Holidays, PTO
Job Type: Full-Time On-site
Typical Hours: Monday-Friday, 40-45 hours per week
Start Date: ASAP
Sponsorship is not available
Relocation assistance is available

Manufacturing Quality Engineer - Medical Devices Description

Our client in precision manufacturing is looking for a Manufacturing Quality Engineer near Waterbury, CT. You will lead customer quality investigations, support process validation, and improve inspection methods for regulated, precision-molded components. You will work closely with engineering, manufacturing, quality, and metrology teams. This hands-on role includes measurement programming, root-cause analysis, statistical studies, and new-product quality support. To qualify, you must have medical-device manufacturing or ISO 13485 experience. You must also understand injection molding or a comparable precision-manufacturing process. This role offers ownership of varied technical projects and a potential path into quality management, regulatory affairs, or another leadership position.

Manufacturing Quality Engineer - Medical Devices Responsibilities

  • Lead customer complaint, containment, and corrective-action activities
  • Communicate investigation findings and preventive actions to customers
  • Perform root-cause analysis and verify long-term corrective actions
  • Support IQ, OQ, PQ, PPAP, first-article, and product-launch activities
  • Create and analyze CMM or vision-system inspection programs
  • Develop control plans, inspection templates, and measurement methods
  • Apply GD&T when planning measurements, fixtures, and inspection methods
  • Conduct capability studies, GR&R, DOE, and other statistical analyses
  • Support inspectors and metrologists with training and troubleshooting
  • Recommend equipment and automation to improve inspection throughput
  • Design or define gauges, fixtures, and inspection tooling
  • Lead projects that reduce scrap, process variation, labor, and COPQ

Manufacturing Quality Engineer - Medical Devices Qualifications

  • 3+ years of quality experience in medical-device or ISO 13485 manufacturing required
  • Injection-molding or precision-manufacturing experience required
  • Customer complaint, CAPA, root-cause, and defect investigation experience required
  • CMM or vision-system programming experience required
  • IQ/OQ/PQ, PPAP, or process validation experience required
  • Proficiency with GD&T and statistical analysis required
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About #twiceasnice Recruiting

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#twiceasnice Recruiting is a prominent company in the recruitment and staffing industry, based in Boston, MA, US. The company's services are designed to meet all employment needs of its clients, focusing on optimal fits between employers and prospective employees. Ever since its inception, #twiceasnice Recruiting has committed to the goal of providing high quality recruitment services at a swift pace. They have garnered significant acclaim for their innovative approaches and prompt services, leading them to be recognized as a leader in their field.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Boston, MA, US

Year founded

2017

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