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Quality Engineer Medical Device Jobs (NOW HIRING)

Stark Pharma Solutions Inc

Quality Engineer

Cambridge, MA · On-site

$78K - $101K/yr

Medical Device / Pharmaceutical Job Summary We are seeking a highly motivated and detail-oriented Quality Engineer to support quality assurance and compliance activities within a GMP-regulated ...

Dexian

Quality Engineer (Medical Devices)

Warrendale, PA · On-site

$55 - $75/hr

QUALITY ENGINEER Duration :6 Months (Contract) Location: Warrendale PA Pay rate: $55-75/hr On W2 ... • FDA/Medical Device quality experience preferred • Strong MS Office and Excel skills ...

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Quality Engineer Medical Device information

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

As of Jun 29, 2026, the average hourly pay for quality engineer medical device in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What does a Quality Engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the key skills and qualifications needed to thrive as a Quality Engineer in the medical device industry, and why are they important?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

What Does a Quality Engineer for Medical Devices Do?

As a quality engineer for medical devices, you oversee the continual improvement of medical devices as well as the design and manufacturing of new devices. Your duties are to develop prototypes, assess the quality of manufacturing standards, and develop guidelines for technological improvement. You also work closely with medical device engineers to ensure sufficient documentation and standardization, which helps users and service technicians test and maintain the safety of devices. Your responsibilities as a medical device quality engineer relate to all aspects of the product life cycle, from prototyping to the supply chain to production.

How does a Quality Engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
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What cities are hiring for Quality Engineer Medical Device jobs? Cities with the most Quality Engineer Medical Device job openings:
What are the most commonly searched types of Quality Engineer Medical Device jobs? The most popular types of Quality Engineer Medical Device jobs are:
What states have the most Quality Engineer Medical Device jobs? States with the most job openings for Quality Engineer Medical Device jobs include:
What job categories do people searching Quality Engineer Medical Device jobs look for? The top searched job categories for Quality Engineer Medical Device jobs are:
Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in the United States as of June 2026, with employment types broken down into 90% Full Time, and 10% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Quality Engineer

Stark Pharma Solutions Inc

Cambridge, MA • On-site

$78K - $101K/yr

Contractor

Posted 18 days ago

Key responsibilities

  • Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO 13485 requirements.

  • Review and approve deviations, non-conformances, CAPAs, and change controls.

  • Conduct root cause investigations and implement corrective and preventive actions.

Job description

Hi,

My name is Sravani Dasari, and I am a Talent Acquisition Specialist with
Stark Pharma Solutions, specializing in opportunities across the
Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.
I am actively connecting with professionals for current and
upcoming opportunities. If you are open to exploring new roles or would like to
stay informed about relevant positions, please send me your updated resume
along with the best number and time to reach you.
You can also follow Stark Pharma Solutions on LinkedIn for the
latest job updates:
https://www.linkedin.com/company/99455976/

Job Title: Quality Engineer
Location: Cambridge , MA
Industry: Medical Device / Pharmaceutical
 

Job Summary

We are seeking a highly motivated and detail-oriented Quality Engineer to support quality assurance and compliance activities within a GMP-regulated Medical Device and Pharmaceutical manufacturing environment. The Quality Engineer will be responsible for maintaining quality systems, supporting investigations, driving continuous improvement initiatives, and ensuring compliance with FDA, cGMP, ISO 13485, and company quality standards. The ideal candidate will work cross-functionally with Manufacturing, Validation, Engineering, and Regulatory teams to ensure product quality and patient safety.

Key Responsibilities

  • Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO 13485 requirements.
  • Review and approve deviations, non-conformances, CAPAs, and change controls.
  • Conduct root cause investigations and implement corrective and preventive actions.
  • Support internal, customer, and regulatory audits and inspections.
  • Review manufacturing, validation, and quality documentation for compliance.
  • Perform risk assessments and quality impact evaluations.
  • Monitor quality metrics and identify opportunities for continuous improvement.
  • Support supplier quality activities, including qualification and performance monitoring.
  • Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle.
  • Assist in process validation, equipment qualification, and product quality improvement initiatives.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Quality, or a related field.
  • 3+ years of Quality Engineering experience in Medical Device, Pharmaceutical, or Biotechnology industries.
  • Knowledge of FDA regulations, cGMP, ISO 13485, and quality systems.
  • Experience with CAPA, deviations, change control, and investigations.
  • Strong problem-solving and root cause analysis skills.
  • Excellent communication and documentation skills.