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Medical Device Qa Jobs (NOW HIRING)

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Medical Device Assembler, Weekend Day 3/12 Schedule

Irvine, CA · On-site

$19 - $20/hr

Medical Device implant manufacturer in Irvine is seeking applicants with manufacturing experience ... quality assurance program, as well as safety and environmental standards. Ability to establish ...

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · Hybrid

$138K - $185K/yr

Manage quality assurance interfaces with medical device suppliers and testing partners in collaboration with External Quality. Who You Are: You are a detail-oriented and dedicated professional with a ...

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · On-site

$138K - $185K/yr

Manage quality assurance interfaces with medical device suppliers and testing partners in collaboration with External Quality. Who You Are: You are a detail-oriented and dedicated professional with a ...

A-dec, Inc.

Quality Assurance Specialist, Sr

Newberg, OR · Remote

$86K - $119K/yr

... Medical Device regulations and standards including US-FDA, Health Canada, and the European Union ... Coaches and mentors Quality Assurance Specialist(s) to grow capabilities and technical acumen.

A-dec, Inc.

Quality Assurance Specialist, Sr

Newberg, OR · On-site

$86K - $119K/yr

... Medical Device regulations and standards including US-FDA, Health Canada, and the European Union ... Coaches and mentors Quality Assurance Specialist(s) to grow capabilities and technical acumen.

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Medical Device Qa information

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$12

$36

$70

How much do medical device qa jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for medical device qa in the United States is $36.79, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $50.00 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a medical device QA, and why are they important?

To thrive as a Medical Device QA, you need a solid understanding of quality assurance principles, regulatory standards (such as ISO 13485 and FDA 21 CFR Part 820), and a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), document control software, and auditing tools is typically required, along with certifications like Certified Quality Auditor (CQA) or Six Sigma. Strong attention to detail, problem-solving abilities, and effective communication help ensure compliance and drive continuous improvement. These skills and qualities are crucial to maintaining product safety, regulatory compliance, and overall quality within the highly regulated medical device industry.

What are some common challenges faced by medical device QA professionals, and how can they be addressed?

Medical Device QA professionals often encounter challenges such as navigating complex regulatory requirements, ensuring product consistency, and keeping up with frequent changes in standards. Addressing these challenges typically involves staying current with FDA and ISO updates, maintaining robust documentation practices, and fostering clear communication with cross-functional teams like R&D and manufacturing. Regular training sessions and proactive risk management strategies also help QA professionals ensure quality and compliance throughout the product lifecycle.

What is a medical device QA?

Medical Device Quality Assurance (QA) professionals are responsible for ensuring that medical devices meet regulatory standards and are safe and effective for use. They develop and implement quality management systems, conduct audits, and oversee documentation throughout the product lifecycle. QA professionals also work closely with engineering, manufacturing, and regulatory teams to identify and resolve quality issues, manage risk, and ensure compliance with industry standards such as ISO 13485 and FDA regulations.

What is the difference between Medical Device Qa vs Medical Device Quality Inspector?

AspectMedical Device QaMedical Device Quality Inspector
CertificationsISO 13485, FDA regulations, Six SigmaISO 13485, FDA regulations, Six Sigma
Work EnvironmentDesign, development, and process oversight in manufacturingInspection and testing on production lines
ResponsibilitiesEnsuring quality systems and complianceInspecting products for defects and conformance

Medical Device Qa professionals focus on quality assurance processes, compliance, and system improvements, while Medical Device Quality Inspectors primarily perform product inspections and defect detection. Both roles require similar certifications and work within the medical device industry, but their daily tasks and focus areas differ significantly.

More about Medical Device Qa jobs
What cities are hiring for Medical Device Qa jobs? Cities with the most Medical Device Qa job openings:
What states have the most Medical Device Qa jobs? States with the most job openings for Medical Device Qa jobs include:
What job categories do people searching Medical Device Qa jobs look for? The top searched job categories for Medical Device Qa jobs are:
Medical Device Qa jobs near you
Infographic showing various Medical Device Qa 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 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $76,520 per year, or $36.8 per hour.

Senior Medical Device Quality Engineer

Prophecy Technologies

Blue Ash, OH • On-site

$81K - $110K/yr

Full-time

Posted 13 days ago

Job description

Role Overview:
This Senior Medical Device Quality Engineer role involves leading multiple high-priority lifecycle change projects from concept through implementation within the medical device or other regulated industries. The position requires strong expertise in design controls, risk management, quality management systems, and process validation to ensure regulatory compliance and product quality.
Key Responsibilities:
  • Lead multiple high-priority lifecycle change projects from concept through implementation.
  • Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
  • Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
  • Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
  • Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
  • Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
  • Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
  • Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
  • Drive root cause analysis, technical problem solving, and timely closure of project issues.
  • Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
  • Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.

Required Skills:
  • Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, and Engineering Change Management (ECO/ECN/ECR).
  • Hands-on experience with Design Verification & Validation (V&V), test methods, protocol development, and technical documentation.
  • Deep understanding of Risk Management methodologies, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
  • Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory compliance requirements.
  • Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM).
  • Proficiency in Process Validation activities including IQ/OQ/PQ, pilot builds, validation builds, and manufacturing transfer.
  • Ability to interpret engineering drawings, GD&T, tolerance stack-ups, specifications, and acceptance criteria.
  • Strong root cause analysis and problem-solving skills utilizing 8D, CAPA, 5 Why, Fishbone, and corrective action processes.
  • Excellent project management skills, including planning, scheduling, risk management, stakeholder management, and cross-functional coordination.
  • Effective leadership, communication, and influencing skills.
  • EIS : MDD Risk Management.

Qualifications:
  • 6-8 years of experience required.
  • 7+ years of engineering experience in medical device or other regulated industries.
  • Experience leading cross-functional technical projects.
  • Experience with component development, supplier qualification, design verification, and manufacturing validation.
  • Strong understanding of design controls, change management, risk management, process validation, and quality system compliance.

Preferred Skills:
  • EIS : New Product Development (NPD) Methodology and Management.

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