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Contract Quality Engineer Medical Device Jobs (NOW HIRING)

IT MINDS L.L.C.

Quality Engineer - Medical Device

Newark, DE · On-site

$70K - $90K/yr

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? • ...

Kelly Services

Quality Engineer

Austin, TX

$71K - $92K/yr

The Contract Quality Engineer will provide technical and quality support for manufacturing operations within an FDA-regulated, ISO 13485 medical device environment. The role primarily focuses on ...

Kelly Services

Quality Engineer

Austin, TX

$71K - $92K/yr

The Contract Quality Engineer will provide technical and quality support for manufacturing operations within an FDA-regulated, ISO 13485 medical device environment. The role primarily focuses on ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Medical Device Quality Engineer Location: Madison, WI Pay Rate : $40--45/hr on W2 Schedule: Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is responsible ...

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All JobsContract Quality Engineer Medical Device Jobs

Contract Quality Engineer Medical Device information

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$45K

$84K

$119K

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

As of Jun 9, 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 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.
More about Contract Quality Engineer Medical Device jobs
What cities are hiring for Contract Quality Engineer Medical Device jobs? Cities with the most Contract Quality Engineer Medical Device job openings:
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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 May 2026, with employment types broken down into 1% As Needed, and 99% Full Time. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.
Quality Engineer Medical Device

Quality Engineer Medical Device

Egg Medical Inc

Roseville, MN • On-site

$100K - $115K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 21 days ago

Job description

Summary

We are seeking a Quality Engineer to add to our team! This position will support the management of our quality system while actively contributing to new product design and development initiatives. This role combines core quality engineering responsibilities with technical involvement in engineering projects to ensure our innovative medical devices meet the highest standards of safety, reliability, and regulatory compliance. 

Key Responsibilities

  • Quality System Support: Develop, implement, and maintain elements of the Quality Management System (QMS) to ensure ongoing compliance with FDA regulations, ISO 13485, and other applicable standards.
  • New Product Development & Design Control: Collaborate with R&D, engineering, and cross-functional teams on new design projects; support design inputs/outputs, risk assessments (e.g., FMEA, ISO 14971), design verification and validation activities, and design reviews/transfer to manufacturing.
  • Risk Management & Technical Reviews: Perform and document risk analyses, participate in technical design reviews, and ensure design controls are effectively applied throughout the product lifecycle.
  • Non-Conformance & Corrective Actions: Investigate non-conformances, lead root cause analysis, and implement corrective and preventive actions (CAPA) to drive continuous improvement and prevent recurrence.
  • Documentation & Compliance: Maintain accurate quality records, support internal/external audits, and contribute to regulatory submissions as needed.
  • Continuous Improvement: Identify opportunities to improve quality processes, product designs, and overall efficiency; partner with engineering and other teams on quality initiatives

Qualifications

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.
  • 3+ years of experience as a Quality Engineer in a regulated industry, preferably medical devices.
  • Experience with FDA regulations, ISO 13485, and other medical device quality standards.
  • Proficiency in quality tools and methodologies (e.g., FMEA, SPC, CAPA).

Compensation & Benefits

  • Full-time position with salary range from $100,000-$115,000, depending on experience.
  • Additional bonus/incentive compensation available.
  • Company laptop provided.
  • Insurance available on the 1st of the month following date of hire, including: health, dental and vision insurance, plus pre-tax or Roth 401k available after 30 days.
  • PTO accrues starting at 15 days, plus 11 company paid holidays.

Company Description

Egg Medical is an innovative leader in radiation safety protection technology. Our mission is to protect healthcare professionals from occupational radiation exposure while enabling the delivery of exceptional patient care.