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Quality Assurance Medical Devices Jobs (NOW HIRING)

Timeck Care Inc.

QA/Medical Coordinator

Antioch, TN · On-site

Medical/QA/Documentation Coordinator Department: Administration Reports to: Executive Director/Administrator Position Summary : Timeck Care Inc. uses best practices and technology within a community ...

Ketryx

QA/RA Consultant

Boston, MA · On-site +1

$130K - $150K/yr

Job Title: QA/RA Consultant Employment Status: Full-time Office Hours: Monday - Friday; hybrid ... medical devices. This position will be based in our Boston, Massachusetts office with a hybrid ...

Ketryx

QA/RA Consultant

Boston, MA · On-site

$130K - $150K/yr

Job Title: QA/RA Consultant Employment Status: Full-time Office Hours: Monday - Friday; hybrid ... medical devices. This position will be based in our Boston, Massachusetts office with a hybrid ...

Transformcap

QA/RA Consultant

Boston, MA · On-site

$130K - $150K/yr

Job Title: QA/RA Lead Employment Status: Full-time Office Hours: Monday - Friday; hybrid schedule ... medical devices. This position will be based in our Boston, Massachusetts office with a hybrid ...

MSD

Associate Director, Quality Assurance

Rahway, NJ · On-site

Lead and manage development of Design and Development File deliverables for medical devices Skills ... Clinical Quality Assurance, Clinical Quality Assurance, Combination Products, Computer System ...

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How much do quality assurance medical devices jobs pay per hour?

As of Sep 12, 2026, the average hourly pay for quality assurance medical devices in the United States is $29.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.75 and $34.38 per hour, depending on experience, location, and employer.

What is a quality assurance role in medical devices?

A Quality Assurance (QA) role in medical devices involves ensuring that products meet regulatory standards and are safe and effective for use. QA professionals develop and maintain quality systems, conduct audits, review documentation, and oversee testing processes to ensure compliance with regulations such as FDA, ISO 13485, and other international standards. They work closely with manufacturing, engineering, and regulatory teams to prevent defects and mitigate risks throughout the product lifecycle. Their work is critical to ensuring patient safety and the reliability of medical devices.

What are the key skills and qualifications needed to thrive as a quality assurance professional in medical devices?

To thrive as a Quality Assurance professional in Medical Devices, you need a solid understanding of regulatory standards (such as ISO 13485 and FDA 21 CFR Part 820), risk management, and quality control principles, often supported by a degree in engineering, life sciences, or a related field. Familiarity with quality management systems (QMS), document control software, and certifications like Certified Quality Auditor (CQA) or Six Sigma are typically required. Attention to detail, critical thinking, and strong communication skills help you effectively identify issues and collaborate across teams. These skills and qualifications are crucial to ensure compliance, patient safety, and the consistent manufacture of high-quality medical devices.

What are some common challenges faced by quality assurance professionals in the medical device industry, and how can they be addressed?

Quality Assurance professionals in the medical device industry often encounter challenges such as keeping up with evolving regulatory standards, ensuring thorough documentation, and maintaining consistent product quality across manufacturing sites. Addressing these challenges typically involves staying updated with global regulations, implementing robust quality management systems, and fostering clear communication between cross-functional teams like R&D, manufacturing, and regulatory affairs. Proactive training and regular internal audits can also help identify and resolve issues before they impact product safety or compliance.

What is the difference between Quality Assurance Medical Devices vs Quality Control Medical Devices?

AspectQuality Assurance Medical DevicesQuality Control Medical Devices
FocusPreventing defects through process improvementDetecting defects through testing and inspection
ResponsibilitiesDeveloping protocols, audits, complianceProduct testing, inspection, defect identification
CertificationsISO 13485, FDA regulationsISO 13485, FDA regulations
Work EnvironmentDocumentation, process management, auditsLaboratories, testing facilities, production lines

While both roles are essential in medical device manufacturing, Quality Assurance Medical Devices focuses on preventing issues through process controls and compliance, whereas Quality Control Medical Devices emphasizes identifying defects through testing. Understanding these differences helps in choosing the right career path or hiring focus within the industry.

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Cities with the most Quality Assurance Medical Devices job openings:

What states have the most Quality Assurance Medical Devices jobs?

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What are popular job titles related to Quality Assurance Medical Devices jobs?

For Quality Assurance Medical Devices jobs, the most frequently searched job titles are:

Quality Assurance Medical Devices jobs near you
Infographic showing various Quality Assurance Medical Devices job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $60,925 per year, or $29.3 per hour.

QA Specialist - GMP & Quality Assurance (Medical Devices)

Deerfield Beach, FL • On-site

SupportFinity™
IT Services • 51 - 200 employees
Learn more about SupportFinity™external

Other

Posted 10 days ago

Key responsibilities

  • Review and approve Production Batch Records and Testing Results to ensure completeness, accuracy, and documentation compliance.

  • Provide oversight and support during manufacturing operations, including reviewing and approving Quality Work Instructions, Technical and Product Specifications, Sampling instructions, and Test Methods.

  • Support investigation processes for Non-Conformances and ensure completion of corrective and preventive actions.

Job description

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.
Job Overview
QA Specialist provides oversight of GMP operations to ensure that products are manufactured according to cGMP requirements and fit for their intended use. Maintains data collected from the manufacturing process, generates, and updates procedures and ensures Batch Records comply with established policies and procedures.
Main Responsibilities

  • Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures.
  • Prepare CofC and CoAs.
  • Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions.
  • Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods.
  • Provides oversight to Risk Management programs, procedures, and documentation for Development and Process Validation activities.
  • Review and approve Test Method Development, Validation, and Transfer activities in support of the Analytical Sciences department.
  • Review and approve Stability Studies protocols and reports.
  • Support the investigation process for Non-Conformances and ensures completion of related corrective and preventive actions.
  • Support the Audit Team with during external and internal audits.
  • Provides support to the program management office with the review and approval of the design transfer package documentation.
  • Provides Quality support for throughout the product lifecycle to include the review of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives.
Skills And Qualification
  • Preferred BS in Engineering, Biology, or other technical related degree
  • A minimum of 4 years of experience in Quality with Pharmaceutical and/or Medical Device based GMP manufacturing operations.
  • Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
  • Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations.
  • Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in area of responsibility.
  • Ability to interact with regulatory agencies. knowledge of FDA, EMA, JP and other regulations.
  • Knowledge of Good Manufacturing Practices & Good Documentation Practices
  • Able to communicate effectively and work within cross-functional teams.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Experience in internal / external audits, identify findings, drive resolution, and provide closure report
  • Proficient skills in solving complex problems and ability to bring issues to resolution.
  • Experience working globally with diverse teams and cultures
We Offer
  • Competitive compensation package
  • Modern working environment with state-of-the-art facilities and technologies
  • Challenging assignments in a fast growing and innovative industry
  • Position in a dynamic, international team of highly skilled professionals
  • Various opportunities for personal and professional development within a global organization
Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.
For more information on SHL Medical, please visit: shl-medical.com

About the company

SHL Medical

Be vigilant about potential scams, phishing attempts, or fraudulent activities, and seek credible sources or reviews to assess the trustworthiness of the company. Remember, your personal and financial security is paramount, and taking preventive measures is crucial to safeguarding your information from potential risks and unauthorized use. SupportFinity is not responsible for any consequences that may arise from disclosing such information to unauthorized or fraudulent entities.

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