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Contract Quality Engineer Medical Device Jobs in Raleigh, NC

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 ...

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 ...

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:

GlaxoSmithKline

Device Engineer

Zebulon, NC

Experience with design controls, risk management and quality processes used in medical device ... Experience working with contract manufacturers, suppliers, or external partners on prototyping and ...

GSK

Device Engineer

Zebulon, NC · On-site

Experience with design controls, risk management and quality processes used in medical device ... Experience working with contract manufacturers, suppliers, or external partners on prototyping and ...

Tekni-Plex

Operations Quality Engineer

Clayton, NC

$69K - $87K/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

$69K - $87K/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 ...

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, Inc.

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 ...

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

$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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Showing results 1-20

All JobsContract Quality Engineer Medical Device JobsContract Quality Engineer Medical Device Jobs in Raleigh, NC

Contract Quality Engineer Medical Device information

See Raleigh, NC salary details

$43.7K

$81.7K

$115.7K

How much do contract quality engineer medical device jobs pay per year?

As of Aug 1, 2026, the average yearly pay for contract quality engineer medical device in Raleigh, NC is $81,693.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,000.00 and $90,400.00 per year, depending on experience, location, and employer.

What is the difference between Contract Quality Engineer Medical Device vs Contract Quality Engineer Pharmaceutical?

AspectContract Quality Engineer Medical DeviceContract Quality Engineer Pharmaceutical
CertificationsISO 13485, FDA QSR, GMPICH Q7, GMP, FDA regulations
Work EnvironmentMedical device manufacturing, labs, compliance auditsPharmaceutical production, labs, quality assurance
Industry UsageMedical device companies, OEMs, suppliersPharmaceutical firms, biotech companies, contract manufacturers

Both roles focus on quality assurance and regulatory compliance but differ mainly in industry-specific standards and environments. Contract Quality Engineers Medical Device work primarily with ISO 13485 and FDA QSR standards in device manufacturing, while Contract Quality Engineers Pharmaceutical focus on GMP and ICH Q7 regulations in drug production. Understanding these differences helps candidates target the right industry and certifications for their career goals.

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

A Contract Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory and company quality standards during a specific project or timeframe. They typically work on a contract basis, focusing on tasks like process validation, risk management, root cause analysis, and compliance with standards such as ISO 13485 and FDA regulations. Their role often involves collaborating with engineering, production, and regulatory teams to troubleshoot quality issues and implement corrective actions. They play a key role in maintaining product safety and regulatory compliance throughout the manufacturing process.

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

To thrive as a Contract Quality Engineer in the Medical Device field, you need expertise in quality assurance, regulatory compliance (such as ISO 13485 and FDA regulations), and a background in engineering or life sciences. Familiarity with tools like CAPA systems, risk management software, and proficiency in quality management systems (QMS) is typically required. Strong analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These skills are essential to ensure product safety, regulatory compliance, and the successful launch and maintenance of medical devices in a highly regulated environment.

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

As a Contract Quality Engineer in the medical device sector, you will frequently work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain. Your responsibilities often involve reviewing design documentation, participating in risk assessments, and ensuring production processes meet both internal quality standards and regulatory requirements. Effective communication is key, as you'll be responsible for conveying quality expectations, addressing non-conformities, and supporting project timelines. This collaborative environment provides valuable experience in coordinating with diverse professionals while upholding strict industry standards.
What are popular job titles related to Contract Quality Engineer Medical Device jobs in Raleigh, NC? For Contract Quality Engineer Medical Device jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Contract Quality Engineer Medical Device jobs in Raleigh, NC look for? The top searched job categories for Contract Quality Engineer Medical Device jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Contract Quality Engineer Medical Device jobs? Cities near Raleigh, NC with the most Contract Quality Engineer Medical Device job openings:
Contract Quality Engineer Medical Device jobs near you

Quality Engineer / Quality Systems Specialist

Stark Pharma Solutions Inc

Durham, NC • On-site

Contractor

Posted 24 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