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Quality Assurance In Medical Devices Jobs (NOW HIRING)

Wondfo

Quality Assurance Specialist II

San Diego, CA · On-site

The quality assurance specialist assists in ensuring that medical devices meet established quality standards and regulatory requirements. This role involves supporting quality assurance activities ...

HC2022 MIM Software Inc.

QA Manager

Beachwood, OH · On-site

At least 7 years of relevant experience in Quality Assurance in a regulated industry (Medical Devices or Pharmaceuticals), preferably with Software as a Medical Device (SaMD). * Demonstrated ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

Quality Assurance / Quality Manager - Medical Devices Location: Chicago area (Headquarters ... This role focuses on both process and product quality assurance, driving continuous improvement in ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

Quality Assurance / Quality Manager - Medical Devices Location: Chicago area (Headquarters ... This role focuses on both process and product quality assurance, driving continuous improvement in ...

Comrise

Senior Quality Assurance Engineer

Redmond, WA · On-site

$70.80/hr

... in medical device technology and healthcare equipment is seeking a Senior Quality Assurance ... Experience: 2+ years of Quality Engineering experience within medical devices, biotechnology, or a ...

New

Guerbet

QA Manager

Princeton, IN · On-site

... in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital ... Quality Assurance * Ensure compliance with the legislative requirements as set out by FDA (21 CFR ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee ... Support quality assurance activities associated with transferring and starting up manufacturing ...

Axogen

Manager, Quality Assurance

Vandalia, OH

... both in the US and OUS for tissue, Medical Devices and/or Biologics. * Knowledge of statistical ... Manages Quality Assurance operations at DPC, APC, or BDC, ensuring compliance with domestic and ...

Abbott

Supervisor Quality Assurance

Westford, MA

... in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues ... Job Title Quality Assurance Supervisor I Working at Abbott At Abbott, you can do work that matters ...

CorDx

Senior QA Manager

Atlanta, GA · On-site

Experience: * 7+ years in QA within IVD, medical devices, or regulated life sciences. * At least 3 ... years in a leadership role. Regulatory Knowledge: * Knowledge of FDA 21 CFR Part 820, ISO 13485 ...

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Quality Assurance In Medical Devices information

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

As of Sep 10, 2026, the average hourly pay for quality assurance in medical devices in the United States is $23.19, according to ZipRecruiter salary data. Most workers in this role earn between $17.55 and $24.28 per hour, depending on experience, location, and employer.

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

AspectQuality Assurance In Medical DevicesQuality Control In Medical Devices
FocusPreventing defects through process improvement and complianceIdentifying and fixing defects in finished products
ActivitiesAudits, process validation, documentation reviewInspections, testing, sampling of products
CredentialsISO 13485, regulatory knowledge, quality management systemsTesting methods, inspection techniques, standards knowledge
Work EnvironmentManufacturing, regulatory agencies, quality departmentsLaboratories, production lines, inspection stations

While both roles aim to ensure product safety and compliance, Quality Assurance In Medical Devices focuses on preventing issues through process controls, whereas Quality Control In Medical Devices emphasizes detecting defects in finished products. Understanding these differences helps in choosing the right career path or hiring focus within the medical device industry.

What cities are hiring for Quality Assurance In Medical Devices jobs?

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What states have the most Quality Assurance In Medical Devices jobs?

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

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

Quality Assurance In Medical Devices jobs near you
Infographic showing various Quality Assurance In Medical Devices job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $48,237 per year, or $23.2 per hour.

Quality Assurance Specialist - Medical Devices

Harleysville, PA • On-site

Medical Components, Inc
Medical Equipment and Supplies Manufacturing • 51 - 200 employees
Learn more about Medical Components, Incexternal

Full-time

Posted 6 days ago

Job description

Quality Assurance Specialist
Full-Time | Onsite | Harleysville, PA
Position Summary
MedComp is seeking a Quality Assurance Specialist to support our Quality Management System (QMS) and ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and internal quality requirements. The role serves as a delegated Quality Assurance authority for Device History Record (DHR) review and product release activities while supporting Change Control, Validation Review, CAPA, and Quality System compliance.
The ideal candidate is a detail-oriented quality professional with experience in medical device manufacturing or another regulated industry who thrives in a collaborative, fast-paced environment.
Key Responsibilities
  • Review DHR and supporting documentation to ensure compliance with product specifications and quality requirements.
  • Provide final QA disposition and release of finished products.
  • Review and approve product, process, and quality system changes through the Change Control process.
  • Evaluate validation documentation, risk assessments, and supporting recrods for adequacy and compliance.
  • Support investigations, nonconformances, root cause analysis, and CAPA.
  • Assess Quality System changes and coordinate cross-functional impact assessments.
  • Support supplier quality activities, including supplier corrective actions and investigations.
  • Monitor quality metrics and trends and recommend process improvements.
  • Assist with internal audits, customer audits, and regulatory inspections.
  • Develop and maintain quality procedures, work instructions, and related documentation.
  • Partner with Production, Engineering, Regulatory Affairs, and Operations to support compliance and continuous improvement initiatives.
Qualifications
Required
  • Bachelor's degree in Engineering, Life Sciences, or a related field, or an equivalent combination of education and experience.
  • 2-5 years of Quality Assurance experience in a medical device manufacturing environment or other regulated industry.
  • Working knowledge of FDA 21 CFR Part 820, ISO 13485, and QMS
  • Experience with DHR review, document review, investigations, or quality system processes.
  • Strong analytical, problem-solving, and communication skills.
  • Proficiency with Microsoft Office and electronic QMS.
Preferred
  • Experience with Change Control, CAPA, Validation, Risk Management, and Supplier Quality processes.
  • Experience supporting regulatory inspections and audits.
  • CQA, CQE, Six Sigma, or similar certification.
  • ISO 13485 Lead Auditor certification.

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