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Medical Device Quality Engineer Resume Jobs (NOW HIRING)

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Medical Device Quality Engineer Location: Madison, WI Pay Rate : $40--45/hr on W2 Schedule: Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is responsible ...

Synkriom

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Medical Device Quality Engineer

Warsaw, IN · On-site

$35 - $40/hr

Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred Company Description Founded in 2015 and backed by two decades of hands-on experience, our ...

CSL Plasma Inc.

$115K - $136K/yr

... quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc. * Ensure external medical device development and manufacturing partners meet the ...

Saxon Global

QA ENGINEER

Saint Augustine, FL · On-site

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 ...

Flotec

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Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

How to Apply Qualified candidates are encouraged to submit a resume and brief cover letter outlining their relevant quality engineering and medical device experience. Company Description Flotec is a ...

Kellton Tech

Medical Device Quality Inspector

Madison, WI · On-site

$25 - $30/hr

Medical Device Quality Inspector Location: Madison, WI (Onsite) Pay Rate: $25-30/hr. on W2 **Opportunity to earn overtime pay** The Medical Device Quality Inspection group is responsible for assuring ...

Socket.dev

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 ...

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

As of Sep 10, 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:

Medical Device Quality Engineer

Madison, WI • On-site

Kellton Tech
See more jobs at Kellton Techexternal

$40 - $45/hr

Contractor

Re-posted 28 days ago

Job description

Job Title: Medical Device Quality Engineer
Location: Madison, WI
Pay Rate : $40--45/hr on W2
Schedule: Onsite, Monday–Friday (standard business hours)

SummaryThe Senior Quality Analyst/Engineer is responsible for ensuring compliance and maintaining strong Quality Systems for the Madison facility. This role oversees CAPA, Change Management, investigations, deviations, Quality Management Reviews, audit coordination, and facility-wide quality metrics. The position supports Quality System improvement initiatives, data trending, reporting, audits, and cross-functional collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management to strengthen quality culture.

Principal Responsibilities

  • Develop and maintain Quality System processes, including metrics reporting and tracking
  • Manage CAPA initiation, review, surveillance, and reporting
  • Facilitate site Quality Management Reviews
  • Lead and coordinate the site Change Management process
  • Support and lead root cause analysis through cross-functional teams
  • Lead Good Documentation Practice (GDP) training and Quality on the Floor activities
  • Interpret and apply all applicable regulatory requirements
  • Coordinate and support facility audits by internal and external agencies
  • Manage data collection and reporting for product recalls
  • Perform Quality System trending to support FDA and Management reviews
  • Drive quality culture through site initiatives and procedure improvements
  • Review and approve procedures, protocols, and reports as required

Additional/Non-Essential Responsibilities:

  • Documentation filing and management as needed
  • Support other Quality System functions
  • May be required to lead personnel within or outside the Quality organization

Minimum Requirements

Education & Experience:

  • Bachelor’s degree (or higher) in a science or technology field preferred
  • 5+ years of Quality Assurance experience in a cGMP-regulated environment (medical device experience preferred)

Skills & Competencies:

  • Strong communication, coaching/mentoring, and presentation skills
  • Ability to manage change effectively
  • Self-motivated with strong decision-making abilities
  • Project management skills with a track record of on-time delivery
  • Leadership and emotional intelligence
  • Moderate proficiency in statistics for data trending and interpretation

Technical Competencies:

  • Proficient in Microsoft Excel, Word, and PowerPoint
  • Strong technical writing skills
  • Experience with statistical analysis software (e.g., Minitab preferred)

Organizational Relationship / Scope

This role collaborates closely with Manufacturing, Quality Control, Engineering, Facilities, Materials Management, Regulatory Affairs, and Process Development. Must thrive in a fast-paced environment with strict timelines. Primarily onsite Monday–Friday, with occasional extended hours, weekends, or holidays to support business needs.

Working Conditions

The Senior Quality Analyst will primarily work in an office setting. Limited domestic and international travel may be required.