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Quality Engineer Medical Device Jobs in Raleigh, NC

GlaxoSmithKline

Senior Device Quality Engineer

Zebulon, NC

$75K - $101K/yr

Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices ... Expert (SME) for device quality processes, providing guidance to operations, engineering, and ...

GSK

Senior Device Quality Engineer

Zebulon, NC · On-site

$75K - $101K/yr

Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices ... Expert (SME) for device quality processes, providing guidance to operations, engineering, and ...

Spectrum Staffing Services

Be Seen First

Quality Engineer

Raleigh, NC · On-site

$43 - $45/hr

The Quality Engineer serves as a subject matter expert for quality processes, supplier quality, and ... Bachelor's degree preferred. * 5-7 years of experience within a medical device or regulated ...

DivIHN Integration Inc

Quality Engineer I

Durham, NC · On-site

$69K - $89K/yr

Minimum of 2 years of manufacturing quality engineering experience (preferably in a regulated industry such as health care, medical device, pharmaceutical, etc). Desired Experience/Qualifications:

Siemens Healthineers

Quality Engineer - CARY, NC

Cary, NC · On-site

$89K - $122K/yr

... medical device industry. * Minimum 3 years of experience in Quality Management Systems - 5 to 7 ... developers, researchers, professionals, and skilled specialists, who believe in each individual ...

Tekni-Plex

Operations Quality Engineer

Clayton, NC · On-site

$61K - $79K/yr

JOB SUMMARY TekniPlex is hiring an Operations Quality Engineer for our Clayton, NC facility. The ... Medical device strongly preferred. * Knowledge of quality system principles as outlined in either ...

Tekni-Plex

Operations Quality Engineer

Clayton, NC · On-site

$61K - $79K/yr

JOB SUMMARY TekniPlex is hiring an Operations Quality Engineer for our Clayton, NC facility. The ... Medical device strongly preferred. * Knowledge of quality system principles as outlined in either ...

Corning

Division Quality Engineer I

Durham, NC

$67K - $92K/yr

You'll apply quality engineering principles and statistical methods to ensure products meet ... Experience in life sciences, pharmaceutical, or medical device industries * Knowledge of injection ...

GSK

Device Engineer

Zebulon, NC · On-site

Experience with design controls, risk management and quality processes used in medical device ... Master's degree in engineering or related field and additional device development experience.

GlaxoSmithKline

Device Engineer

Zebulon, NC

Experience with design controls, risk management and quality processes used in medical device ... Master's degree in engineering or related field and additional device development experience.

Ontic

Quality Engineer

Creedmoor, NC

$75K - $90K/yr

You will report to the Quality Engineering Supervisor and will have an onsite work structure in ... Comprehensive medical insurance * Competitive PTO, holiday pay, and sick leave * Company 401K plan ...

Ontic

Quality Engineer

Creedmoor, NC · On-site

$75K - $90K/yr

You will report to the Quality Engineering Supervisor and will have an onsite work structure in ... Comprehensive medical insurance * Competitive PTO, holiday pay, and sick leave * Company 401K plan ...

Novanta

Quality Engineer

Apex, NC · On-site

$54K - $70K/yr

We create for our global customers engineered components and sub-systems that deliver extreme ... This position provides a full range of medical, financial, and other benefits to make your quality ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in Raleigh, NC

Quality Engineer Medical Device information

See Raleigh, NC salary details

$20

$35

$68

How much do quality engineer medical device jobs pay per hour?

As of Jul 15, 2026, the average hourly pay for quality engineer medical device in Raleigh, NC is $35.70, according to ZipRecruiter salary data. Most workers in this role earn between $24.09 and $44.62 per hour, 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 medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

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

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

What Does a Quality Engineer for Medical Devices Do?

As a quality engineer for medical devices, you oversee the continual improvement of medical devices as well as the design and manufacturing of new devices. Your duties are to develop prototypes, assess the quality of manufacturing standards, and develop guidelines for technological improvement. You also work closely with medical device engineers to ensure sufficient documentation and standardization, which helps users and service technicians test and maintain the safety of devices. Your responsibilities as a medical device quality engineer relate to all aspects of the product life cycle, from prototyping to the supply chain to production.

How does a Quality Engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
More about Quality Engineer Medical Device jobs
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What cities near Raleigh, NC are hiring for Quality Engineer Medical Device jobs? Cities near Raleigh, NC with the most Quality Engineer Medical Device job openings:
Quality Engineer Medical Device jobs near you

Quality Engineer / Quality Systems Specialist

Stark Pharma Solutions Inc

Durham, NC • On-site

Contractor

Posted 6 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Quality Engineer/Quality Systems Specialist position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: Contract Quality Engineer / Quality Systems Specialist

Location: Durham, NC
Duration: Long Term
 

Job Overview

We are seeking an experienced Quality Engineer / Quality Systems Specialist to support a fast-paced FDA-regulated medical device manufacturing environment. This role will focus on driving CAPAs, Non-Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements.

Key Responsibilities

  • Manage and drive CAPAs and Non-Conformance investigations to timely closure.
  • Support Complaint Handling, Audit Readiness, and Risk Management activities.
  • Conduct root cause investigations and implement effective corrective and preventive actions.
  • Ensure compliance with FDA regulations, ISO 13485, and internal Quality System requirements.
  • Collaborate with Manufacturing, Engineering, and Quality teams to resolve quality issues.
  • Support continuous improvement initiatives and maintain Quality Systems documentation.

Required Qualifications

  • Experience in Quality Engineering or Quality Systems within the Medical Device industry.
  • Hands-on experience with CAPA, Non-Conformances, Complaints, Audits, and Risk Management.
  • Strong knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
  • Proven root cause analysis and investigation experience.
  • Excellent problem-solving, communication, and documentation skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com