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Quality Engineer Medical Devices Jobs (NOW HIRING)

IT MINDS L.L.C.

Quality Engineer - Medical Device

Newark, DE · On-site

$70K - $90K/yr

Required: • 3-6+ years of experience in Quality Engineering (QE) and/or Manufacturing Engineering within Medical Devices • Strong experience leading or supporting: o Process FMEAs o Risk ...

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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.
Engineer, Medical Devices (JP12013)

Engineer, Medical Devices (JP12013)

3 Key Consulting

Thousand Oaks, CA

$37 - $41/hr

Other

Posted 29 days ago

Job description

Job Title:Engineer, Medical Devices (JP12013)
Location:Thousand Oaks, CA. 91320
Business Unit:PFS And Lyo Kit Platforms
Employment Type: Contract
Duration:1+ years with possible extensions or conversion to FTE
Rate: $37 - $41/hour W2
Posting Date:11/27/2023
Notes:ONSITE - no remote, heavy lab role. considering candidates in a reasonable radius from the thousand oaks site.
3 Key Consulting is recruiting anEngineerfor a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: Excellent communication, forced testing software experience, design verification testing, proficiency with MS suite. Bachelors relevant engineering or any scientific field as long as they have hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab). Willing to consider those with relevant internship experience.
Job Description:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, and defend inspection and ensure the follow through of commitments.
Basic Qualifications:
Master degree
OR Bachelor degree and 2 years of experience
OR Associate degree and 6 years of experience
Top Must Have Skill Sets:
  • Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
  • Good Communication and Technical Writing Skills
  • Ability to Multitask

Day to Day Responsibilities:
  • The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space.
  • The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems.
  • The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material.
  • Fill-Finish experience is a bonus but not mandatory.
  • Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

Employee Value Proposition: great opportunity for growth in career
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
  • No previous industry or laboratory experience
  • Unfamiliar with Good Documentation Practices
  • Poor communication
  • No technical writing.

Interview Process:
Individual Interviews (x2) - Webex or In-person
Panel Interview (x1) - Webex
We invite qualified candidates to sendyour resume torecruiting@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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