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Quality Engineer Medical Devices Jobs in Delaware

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 management ...

Hologic

Product Quality Engineer 3

Newark, DE · On-site

$85K - $133K/yr

Join a high-growth, world-class manufacturing facility producing life-saving medical devices. Job Summary: Product Quality Engineer will make a direct impact on patient safety and product excellence ...

Hologic Inc.

Product Quality Engineer 3

Newark, DE · On-site

$85K - $133K/yr

Join a high-growth, world-class manufacturing facility producing life-saving medical devices. Job Summary: Product Quality Engineer will make a direct impact on patient safety and product excellence ...

Hologic Inc.

Product Quality Engineer 1

Newark, DE · On-site

$55K - $86K/yr

Join a high-growth, world-class manufacturing facility producing life-saving medical devices. Job Summary: Product Quality Engineer will make a direct impact on patient safety and product excellence ...

Hologic

Product Quality Engineer 1

Newark, DE · On-site

$55K - $86K/yr

Join a high-growth, world-class manufacturing facility producing life-saving medical devices. Job Summary: Product Quality Engineer will make a direct impact on patient safety and product excellence ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market ...

Hologic

Manufacturing Quality Engineer

Newark, DE · On-site

$72K - $93K/yr

Provide quality engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and ...

Hologic Inc.

Manufacturing Quality Engineer

Newark, DE · On-site

$72K - $93K/yr

Provide quality engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and ...

Dupont

Quality Engineer

Newark, DE · On-site

$70K - $90K/yr

... devices from smartphones to electric vehicles, or protecting workers around the world. Discover the ... Why Join Us | DuPont Careers DuPont is looking for a Quality Engineer that will serve as the ...

Hologic Inc.

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation ...

Hologic

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation ...

Hologic

Senior Manufacturing Quality Engineer

Newark, DE · On-site

$97K - $125K/yr

Experience troubleshooting mechanical or electrical medical devices is preferred. • Knowledge of ... Quality Engineer is beneficial. Why join Hologic? We are committed to making Hologic the ...

Intellectt INC

Failure Analysis Engineer

Newark, DE · On-site

Medical Devices We are looking for a Failure Analysis Engineer with experience in troubleshooting medical devices, performing root cause analysis, and supporting quality investigations. Key ...

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Showing results 1-20

All JobsQuality Engineer Medical Devices JobsQuality Engineer Medical Devices Jobs in Delaware

Quality Engineer Medical Devices information

See Delaware salary details

$45K

$84.1K

$119.1K

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

As of Aug 6, 2026, the average yearly pay for quality engineer medical devices in Delaware is $84,111.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,100.00 and $93,100.00 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.
What are popular job titles related to Quality Engineer Medical Devices jobs in Delaware? For Quality Engineer Medical Devices jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Quality Engineer Medical Devices jobs in Delaware look for? The top searched job categories for Quality Engineer Medical Devices jobs in Delaware are:
What cities in Delaware are hiring for Quality Engineer Medical Devices jobs? Cities in Delaware with the most Quality Engineer Medical Devices job openings:
Quality Engineer Medical Devices jobs near you
Infographic showing various Quality Engineer Medical Devices job openings in Delaware as of August 2026, with employment types broken down into 3% As Needed, 83% Full Time, 3% Part Time, and 11% Contract. Highlights an 97% In-person, and 3% Remote job distribution, with an average salary of $84,111 per year, or $40.4 per hour.

Quality Engineer - Medical Device

IT MINDS L.L.C.

Newark, DE • On-site

$70K - $90K/yr

Contractor

Re-posted 20 days ago

Job description

Role: 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?

•              We are seeking experienced Quality and/or Manufacturing Engineers to support a large-scale production documentation and remediation initiative at our client’s Newark, Delaware manufacturing site. These professionals will play a critical role in strengthening risk management practices, supporting transfer to manufacturing activities, and driving process validation and equipment qualification efforts.

o             This engagement will begin with comprehensive documentation gap assessments across multiple production lines, followed by remediation and implementation activities to ensure manufacturing readiness and compliance.

-            

Quality Engineer (Remediation)

Documentation Gap Analysis

•              Perform detailed reviews of production line documentation, including:

o             Process documentation

o             Work instructions

o             Training records

o             Validation documentation

o             Specifications and technical drawings

•              Identify documentation gaps, inconsistencies, and compliance risks.

•              Partner cross-functionally with manufacturing, quality, and engineering teams to prioritize findings.

Remediation & Implementation

•              Develop and execute remediation plans following gap assessments.

•              Update and create SOPs, work instructions, and validation documentation as needed.

•              Support transfer-to-manufacturing activities through structured risk mitigation.

•              Ensure documentation aligns with regulatory and internal quality standards.

Risk Management & FMEA

•              Lead and/or support:

o             Process FMEAs

o             Risk assessments tied to manufacturing transfer

o             Risk mitigation planning and documentation

•              Apply strong risk management principles to process validation and equipment qualification activities.

Process Validation & Equipment Qualification

•              Support process validation activities including:

o             IQ/OQ/PQ execution

o             Equipment qualification documentation

o             Validation protocol review and approval

•              Ensure alignment between validation activities and risk management outputs.

Technical Review & Support

•              Review engineering drawings and specifications to confirm accuracy and alignment with production processes.

o             Ability to read and interpret drawings is required (drafting not required).

•              Support sampling plan assessments:

o             Evaluate sampling plans and statistical justifications

o             Determine appropriate sample sizes and rationale

•              Participate in production line startup and manufacturing support as needed.

Skills:

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 management initiatives

o             Process validation activities

•              Experience reviewing and remediating manufacturing documentation.

•              Working knowledge of equipment qualification (IQ/OQ/PQ).

•              Ability to interpret engineering drawings and technical specifications.

Desired:

•              Experience with instrumentation and electronics (strong plus for the Delaware site).

•              Experience assessing sampling plans and statistical justifications (preferred but not required).

•            

•              Exposure to:

o             Plastics manufacturing

o             Chemistry-based processes or test strip formulation

o             Experience supporting multi-site environments.

Best Regards,

 

Satya Satish J | Technical Recruiter | IT Minds LLC |