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Medical Device Quality Engineer Resume Jobs (NOW HIRING)

Heartflow

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery ... As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality ...

GSK

$75K - $101K/yr

... biotech or medical device manufacturing in a Quality, Validation or Engineering role with ... significant exposure to manufacturing/packaging equipment and devices.Experience supporting or ...

IT MINDS L.L.C.

Quality Engineer - Medical Device

Newark, DE · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Location: Delaware Largescale Medical Device client facing a remediation project here on site in Delaware. What is the project the contractor will be working on?

GlaxoSmithKline

Senior Device Quality Engineer

Zebulon, NC · On-site

$75K - $101K/yr

Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices ... Please submit your resume and a brief cover note outlining your relevant experience and interest in ...

GSK

Senior Device Quality Engineer

Zebulon, NC · On-site

$75K - $101K/yr

Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices ... Please submit your resume and a brief cover note outlining your relevant experience and interest in ...

Biopharma Careers

Senior Device Quality Engineer

Zebulon, GA · On-site

$79K - $107K/yr

Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices ... Expert (SME) for device quality processes, providing guidance to operations, engineering, and ...

Astrix Inc

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

Pay Rate Low: 40.00 | Pay Rate High: 44.00 Exciting Quality Engineer II development opportunity to ... Working knowledge of ISO 13485, ISO 14971, and medical device quality systems. * Strong ...

Amphenol Alden Products

Quality Engineer

Stoughton, MA · On-site

$75K - $85K/yr

The medical device quality engineer supports the development, manufacture, and ongoing compliance of medical devices with a regulated quality management system. This role is responsible for ensuring ...

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Medical Device Quality Engineer Resume information

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

As of Sep 11, 2026, the average hourly pay for medical device quality engineer resume 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 is a medical device quality engineer?

A Medical Device Quality Engineer resume is a document that outlines your experience, skills, and qualifications specific to quality engineering roles within the medical device industry. It typically highlights your knowledge of regulatory standards (like FDA or ISO 13485), experience with quality assurance processes, risk management, and validation techniques. Employers look for resumes that demonstrate your ability to ensure product safety, compliance, and continuous improvement. A strong resume will also showcase your problem-solving abilities and any relevant certifications or technical proficiencies.

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

To thrive as a Medical Device Quality Engineer, you need a solid background in engineering, knowledge of quality assurance principles, and familiarity with regulatory standards such as ISO 13485 and FDA 21 CFR Part 820. Proficiency with quality management systems (QMS), risk analysis tools like FMEA, and software for document control is typically required, and certifications such as CQE (Certified Quality Engineer) are highly valued. Strong attention to detail, problem-solving abilities, and effective communication skills help you collaborate across teams and ensure compliance. These skills and qualities are vital for maintaining product safety, ensuring regulatory compliance, and supporting successful product development in the medical device industry.

What are some common challenges medical device quality engineers face when balancing regulatory compliance with project timelines?

Medical Device Quality Engineers often encounter the challenge of ensuring strict regulatory compliance while meeting demanding project deadlines. Navigating evolving FDA and ISO standards, coordinating with cross-functional teams, and managing documentation can create time pressures. Effective communication and proactive planning help mitigate delays, but unanticipated non-conformities or audits can still impact schedules. Being adaptable and detail-oriented is key to successfully balancing compliance and timely product delivery.

What are popular job titles related to Medical Device Quality Engineer Resume jobs?

For Medical Device Quality Engineer Resume jobs, the most frequently searched job titles are:

Supplier Quality Engineer

Bridgeport, CT • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted yesterday

Job description

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager 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/

Role: Supplier Quality Engineer

Location: Bridgeport Area, CT

Duration: 6-Month Contract

Position Overview

We are seeking experienced Supplier Quality Engineers to support a medical device quality remediation initiative. This role will focus on supplier quality operations, remediation activities, quality system improvements, and supplier performance management within a regulated medical device environment.

The ideal candidate will have a strong background in supplier quality engineering, remediation projects, injection molding suppliers, and quality system processes including NCMRs, SCARs, and CAPAs.

Key Responsibilities

  • Support supplier quality remediation activities within a medical device manufacturing environment.
  • Lead and manage supplier-related quality investigations, nonconformances, and corrective action initiatives.
  • Review, develop, and maintain Supplier Quality documentation and records.
  • Drive closure of supplier quality issues through effective root cause analysis and corrective actions.
  • Manage and support:
  • Nonconforming Material Reports (NCMRs)
  • Supplier Corrective Action Requests (SCARs)
  • Corrective and Preventive Actions (CAPAs)
  • Collaborate with suppliers to improve quality performance and ensure compliance with regulatory requirements.
  • Support supplier qualification, monitoring, and ongoing quality improvement initiatives.
  • Partner with cross-functional teams including Quality, Manufacturing, Engineering, and Supply Chain.
  • Ensure supplier quality processes align with QMS requirements and remediation objectives.
  • Organize and maintain supplier quality documentation to support audit readiness and compliance efforts.

Required Qualifications

  • 7+ years of Supplier Quality Engineering experience within the Medical Device industry.
  • Proven experience supporting Quality System remediation projects from a Supplier Quality perspective.
  • Hands-on experience managing NCMRs, SCARs, CAPAs, and supplier quality investigations.
  • Strong understanding of FDA Quality System Regulations and ISO 13485 requirements.
  • Experience working with injection molding suppliers and manufacturing processes.
  • Demonstrated experience developing, reviewing, and maintaining supplier quality documentation.
  • Strong problem-solving, root cause analysis, and communication skills.