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Medical Device Quality Control Jobs (NOW HIRING)

Tyber Medical LLC

Quality Inspector

Bethlehem, PA

Medical Device QC Inspector Your responsibilities Position Summary: The QC Inspector will be responsible for performing inspection on medical devices to specified requirements to determine product ...

B. Braun Group

VP, QA Franchise (Med Device)

Allentown, PA · On-site

$260K - $290K/yr

VP, QA Franchise (Med Device) Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Allentown ... with Design Control requirements, risk management principles (ISO 14971), and BBMI quality ...

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Heartflow

Senior Device Quality Engineer

San Francisco, CA · Hybrid

$160K - $180K/yr

You will bridge the gap between rapid Agile development and rigorous medical device regulations ... Your core responsibility will be the hands-on management of the end-to-end design control process ...

Saxon Global

QA ENGINEER

Saint Augustine, FL

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

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Medical Device Quality Control information

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How much do medical device quality control jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for medical device quality control in the United States is $21.48, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $24.04 per hour, depending on experience, location, and employer.

What is medical device quality control?

Medical Device Quality Control refers to the processes and procedures used to ensure that medical devices meet safety, quality, and regulatory standards before they reach the market. This involves rigorous inspection, testing, and documentation throughout the manufacturing process to prevent defects and ensure consistent product performance. Quality control professionals work to identify issues, monitor compliance with industry regulations like ISO 13485 and FDA requirements, and help maintain the integrity of healthcare products. Their role is crucial in protecting patient safety and upholding the reputation of medical device manufacturers.

What are the key skills and qualifications needed to thrive as a medical device quality control professional?

To thrive in Medical Device Quality Control, you need a solid understanding of quality assurance principles, regulatory standards (such as ISO 13485 or FDA 21 CFR Part 820), and experience with inspection techniques, often supported by a degree in engineering or life sciences. Familiarity with tools like statistical process control (SPC) software, electronic quality management systems (eQMS), and documentation protocols is typical. Attention to detail, problem-solving abilities, and strong communication skills are essential soft skills for excelling in this role. These competencies are crucial for ensuring product safety, regulatory compliance, and maintaining the reputation of the medical device manufacturer.

What are some common challenges faced in a medical device quality control role, and how can I prepare for them?

Professionals in Medical Device Quality Control often face challenges such as keeping up with evolving regulatory standards, managing documentation for audits, and ensuring consistent product quality across batches. To prepare, it's helpful to develop strong attention to detail, stay updated on FDA and ISO guidelines, and build effective communication skills to collaborate with cross-functional teams like manufacturing and R&D. Being proactive in identifying potential risks and participating in continuous improvement initiatives can also help you succeed in this role.

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

AspectMedical Device Quality ControlMedical Device Quality Assurance
FocusInspecting and testing products to identify defectsDeveloping and maintaining quality systems and processes
ActivitiesProduct testing, inspection, samplingAudits, process validation, compliance management
CertificationsISO 13485, GMP trainingISO 13485, regulatory standards
Work EnvironmentLaboratories, manufacturing floorsQuality departments, regulatory offices

Medical Device Quality Control focuses on testing and inspecting products to ensure they meet quality standards, while Medical Device Quality Assurance emphasizes establishing systems and processes to prevent defects and ensure compliance. Both roles are essential in maintaining high-quality medical devices and often work closely within the industry.

Is medical device quality control a good career?

Medical device quality control involves inspecting and testing devices to ensure they meet safety and regulatory standards, often requiring knowledge of quality management systems and industry regulations. It offers stable employment opportunities with potential for advancement and typically requires attention to detail and relevant certifications. The field is essential for patient safety and is considered a reliable career path within the healthcare manufacturing industry.
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Medical Device Quality Control jobs near you
Infographic showing various Medical Device Quality Control 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 $44,668 per year, or $21.5 per hour.

Quality Engineer Medical Device

Egg Medical Inc

Roseville, MN • On-site

$100K - $115K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 4 hours 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.