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Contract Quality Engineer Medical Device Jobs (NOW HIRING)

Astrix Inc

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

Irvine, CA (Onsite) Contract: 12 month Contract with extension or conversion potential Benefits ... Working knowledge of ISO 13485, ISO 14971, and medical device quality systems. * Strong ...

WilsonCTS

Quality Assurance Engineer - (850-1)

Mahwah, NJ · On-site

$72K - $93K/yr

Quality Engineer (Medical Device Manufacturing) Location: Mahwah, NJ (On-site) Duration: 12-Month Contract (Potential for Extension) Pay Rate: Open/Competitive About the Opportunity Our client, a ...

Flotec

Be Seen First

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based medical device manufacturer specializing in respiratory and oxygen delivery equipment. We manufacture ...

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

As of Sep 6, 2026, the average yearly pay for contract quality engineer medical device 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 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?

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 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.

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Contract Quality Engineer Medical Device jobs near you
Infographic showing various Contract Quality Engineer Medical Device 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.

Quality Engineer Medical Device Manufacturing

Dynaflex Technologies Inc.

Irvine, CA • On-site

$76K - $99K/yr

Other

Posted 6 days ago

Job description

Company Description DynaFlex Technologies Inc. is a global contract manufacturer specializing in catheter assemblies and thermoplastic extrusion for the medical device industry. The Corporate Headquarters in Irvine and Yorba Linda focuses on catheter technology development and advanced melt extrusion. A Rapid Prototyping Lab in Fremont supports quick-turn delivery systems prototyping and process development. The production facility in Taiwan provides turnkey contract manufacturing services for high-volume commercial builds, enabling end-to-end solutions from concept to scaled production. Team members collaborate across locations to deliver high-quality, innovative products to medical device partners worldwide.

Role Description The Quality Engineer, Medical Device Manufacturing, is a full-time on-site role based in Irvine, CA. This role is responsible for overseeing product quality in catheter manufacturing, including developing and maintaining quality processes, procedures, and documentation in accordance with medical device regulations. Day-to-day tasks include performing inspections and tests, analyzing quality data and metrics, investigating nonconformances, and implementing corrective and preventive actions (CAPA). The Quality Engineer collaborates closely with engineering, production, and supply chain teams to ensure compliant processes, robust validations, and continuous improvement of manufacturing operations. The role also supports internal and external audits, risk management activities, and alignment with customer and regulatory requirements.

Qualifications

  • Demonstrated skills in Quality Engineering and Quality Management for medical device manufacturing.
  • Experience in Quality Control methods, including inspection techniques, testing, and data analysis.
  • Proficiency in Quality Assurance activities, such as documentation control, audits, and compliance with ISO 13485 and FDA regulations.
  • Ability to manage Product Quality, including root cause analysis, CAPA, and continuous improvement initiatives.
  • Bachelor’s degree in Engineering, Science, or a related technical field; advanced degree or relevant certifications (e.g., CQE) are a plus.
  • Familiarity with catheter manufacturing processes, extrusion, and cleanroom production environments preferred.
  • Experience with validation (IQ/OQ/PQ), statistical process control, and risk management tools (e.g., FMEA).
  • Strong communication skills and ability to work collaboratively with cross-functional teams in a regulated environment.

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