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Contract Quality Engineer Medical Device Jobs (NOW HIRING)

Talentry, LLC

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Sr. Mechanical Engineer - Medical Device

San Diego, CA · On-site

$130K - $180K/yr

Senior Mechanical Engineer - Medical Device San Diego, CA (Onsite) 130,000-180,000 DOE Join a ... You'll work closely with systems, electrical, quality, regulatory, operations, and lab teams to ...

Astrix Inc

Instrumentation Quality Engineer

Lake Forest, CA · On-site

$76K - $98K/yr

... contract with extension or conversion potential Pay: 38.00-44.00 DOE Benefits: Medical, Dental, Holiday, PTO 401K matching We are seeking an Instrumentation Quality Engineer to support medical device ...

Spryte Medical Inc

Quality Engineer (Contract)

Bedford, MA · On-site

$45 - $55/hr

The Quality Engineer participates in all phases of the product development process. This includes ... Experience in medical device design assurance * Experience in design verification and transfer to ...

Actalent

Medical Device Engineer

Aurora, CO · Hybrid

$57.69/hr

Partner with Quality, Regulatory Affairs, Manufacturing, and R&D teams throughout the product ... Job Type & Location This is a Contract position based out of Centennial, CO. Pay and Benefits The ...

Mitovation

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Systems Engineer - Medical Device Company

Ann Arbor, MI · On-site

$110K - $140K/yr

Support buildout of a Quality Management System (QMS) in anticipation of future ISO 13485 ... Experience working alongside a contract manufacturer or external build partner on clinical or early ...

New

Intellectt INC

Quality Engineer

Plano, TX · On-site

$68K - $89K/yr

We are seeking a detail-oriented and well-rounded Quality Engineer (QE) with experience in the medical device industry. The ideal candidate will support quality systems, validation activities, and ...

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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 Aug 8, 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?

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.
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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 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Medical Device DHF Engineer

Prophecy Technologies

Indianapolis, IN • On-site

Full-time

Posted 13 days ago

Job description

Role Overview:
This role focuses on supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The specialist will be responsible for reviewing, updating, and maintaining critical documentation such as dFMEA, uFMEA, and Preliminary Hazard Analysis (PHA), ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
  • Support and manage Design History File (DHF) activities for medical device projects.
  • Review, update, and maintain Global dFMEA and uFMEA documentation, identifying and mitigating risks.
  • Develop and update Preliminary Hazard Analysis (PHA) in line with risk management procedures.
  • Support the creation and maintenance of product risk management files throughout the development lifecycle.
  • Prepare, review, and update Product Characterization documents, Product Specification Documents (PSD), and Critical-to-Quality (CTQ) documents.
  • Support the development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
  • Ensure robust traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
  • Collaborate cross-functionally with Design, Quality, Regulatory, Manufacturing, and Project Management teams.
  • Participate in design reviews, providing technical input on risk management and DHF compliance.
  • Support engineering change assessments and associated documentation updates.
  • Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
  • Identify documentation gaps and recommend corrective actions.
  • Support audits, inspections, and compliance activities related to design control and risk management documentation.
  • Contribute to continuous improvement initiatives for product development and design control processes.
  • Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.

Required Skills:
  • Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
  • Experience in supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
  • Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
  • Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.
  • Strong written and verbal communication skills for project plans and inter-departmental collaboration.

Qualifications:
  • Experience in medical device development environments, particularly with Design History File (DHF) and risk management processes.

Apply