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Senior Quality Engineer Medical Device Jobs (NOW HIRING)

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Supplier Engineer Duration: Contract to hire - 6+ Months Location: Arden Hills, MN 55112 Hybrid ... As well as Med device experience. Preferred: * Working knowledge of statistical methods, six sigma ...

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? • ...

Senior Quality Engineer

Marlborough, MA · On-site

$91K - $124K/yr

Senior Quality Engineer (Contract) - Medical Device Location: Onsite - Londonderry, NH or Marlborough, MA Duration: 6 months (likely extension) Job Summary: Seeking a hands-on Senior Quality Engineer ...

Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is ... medical device experience preferred) Skills & Competencies: * Strong communication, coaching ...

Senior Quality Engineer

Seattle, WA · On-site

$100K - $136K/yr

Job Summary We are looking for a Senior Quality Engineer to support manufacturing and supplier ... Medical Device or other regulated manufacturing experience * Process Validation, Equipment ...

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Senior Design Assurance Engineer (Medical Device) Location: Arden Hills, MN Duration: 6/12+ Month ... Job Details: Develops, establishes and maintains quality engineering methodologies, systems, and ...

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Senior Design Assurance Engineer (Medical Device) Location: Arden Hills, MN Duration: 6/12+ Month ... Job Details: Develops, establishes and maintains quality engineering methodologies, systems, and ...

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Senior Quality Engineer Medical Device information

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$60.5K

$105.3K

$146.5K

How much do senior quality engineer medical device jobs pay per year?

As of Jul 2, 2026, the average yearly pay for senior quality engineer medical device in the United States is $105,293.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,500.00 and $120,000.00 per year, depending on experience, location, and employer.

What are Senior Quality Engineers in the medical device industry?

Senior Quality Engineers in the medical device industry are professionals responsible for ensuring that medical devices meet regulatory standards and quality requirements throughout their lifecycle. They lead quality assurance activities, develop and implement testing protocols, coordinate with design and manufacturing teams, and help ensure compliance with relevant regulations such as FDA and ISO standards. Their expertise ensures that products are safe, effective, and reliable for patient use. They also mentor junior engineers and may play a key role in audits and process improvements.

What is the difference between Senior Quality Engineer Medical Device vs Quality Engineer Medical Device?

AspectSenior Quality Engineer Medical DeviceQuality Engineer Medical Device
ResponsibilitiesLead quality initiatives, oversee audits, mentor team membersAssist in quality processes, support audits, perform inspections
Experience & CertificationsTypically 5+ years, often ISO 13485, FDA regulationsEntry to mid-level, basic knowledge of industry standards
Work EnvironmentLeadership roles, cross-functional teams, strategic planningOperational tasks, documentation, compliance support
Usage & IndustryCommonly used in manufacturing, R&D, and quality departmentsUsed across similar settings, often as a stepping stone role

The main difference between a Senior Quality Engineer Medical Device and a Quality Engineer Medical Device lies in experience, responsibilities, and leadership scope. Senior roles involve strategic oversight and mentorship, while standard Quality Engineers focus on supporting quality processes and compliance tasks.

What are the key skills and qualifications needed to thrive as a Senior Quality Engineer in Medical Devices, and why are they important?

To excel as a Senior Quality Engineer in Medical Devices, you need a solid background in engineering, quality assurance, and regulatory compliance, typically with a relevant degree and experience in the medical device industry. Familiarity with ISO 13485, FDA 21 CFR Part 820, risk management tools (such as FMEA), and quality management systems is crucial, and certifications like CQE or Six Sigma are often preferred. Strong problem-solving, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure product safety, regulatory compliance, and the continuous improvement of processes critical to patient outcomes and company success.

How does a Senior Quality Engineer in the medical device industry typically collaborate with cross-functional teams during product development?

As a Senior Quality Engineer in the medical device sector, you will work closely with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain. Your role involves ensuring quality standards are integrated throughout the product lifecycle, from design reviews and risk assessments to process validation and compliance documentation. Regular meetings, joint problem-solving sessions, and clear communication are vital to resolve issues efficiently and maintain regulatory compliance. This collaborative environment helps to ensure both product safety and timely market release.
More about Senior Quality Engineer Medical Device jobs
What cities are hiring for Senior Quality Engineer Medical Device jobs? Cities with the most Senior 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 Senior Quality Engineer Medical Device jobs? States with the most job openings for Senior Quality Engineer Medical Device jobs include:
What job categories do people searching Senior Quality Engineer Medical Device jobs look for? The top searched job categories for Senior Quality Engineer Medical Device jobs are:
Infographic showing various Senior Quality Engineer Medical Device job openings in the United States as of June 2026, with employment types broken down into 9% As Needed, 87% Full Time, 1% Part Time, 2% Temporary, and 1% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $105,293 per year, or $50.6 per hour.
Senior Manufacturing Quality Engineer (Medical Device)

Senior Manufacturing Quality Engineer (Medical Device)

Intellectt INC

Marlborough, MA • On-site

$91K - $124K/yr

Contractor

Posted 12 days ago


Job description

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Manufacturing Quality Engineer (Medical Device) based in Marlborough, MA, with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com  OR +1 (732) 737 8381
Job Title: Senior Manufacturing Quality Engineer (Medical Device)
Location:
Marlborough, MA

Job Summary

Seeking a hands-on Senior Manufacturing Quality Engineer with 5+ years of experience in medical device manufacturing to support production and process quality activities. The role involves process validation, quality documentation, risk management, and collaboration with Manufacturing, Validation, and Operations teams to ensure compliant and efficient manufacturing processes.

Key Responsibilities

  • Provide daily quality engineering support for manufacturing operations.
  • Support production and process quality activities.
  • Lead and support Process Validation and TMV activities.
  • Develop and maintain PFMEA, CAPA, CPQ, and CTQ documentation.
  • Author and update protocols, reports, and quality documents.
  • Collaborate with Manufacturing Engineering, Validation, and Operations teams.
  • Troubleshoot quality issues and drive continuous improvement initiatives.

Required Qualifications

  • 5+ years of Quality Engineering experience in medical device manufacturing.
  • Strong background in production and process quality.
  • Experience with electromechanical medical devices.
  • Hands-on expertise in Process Validation, TMV, PFMEA, CAPA, and CPQ/CTQ.
  • Strong technical writing and documentation skills.
  • Ability to work on the manufacturing floor in a fast-paced environment.

Preferred Qualifications

  • Experience with IVD (In Vitro Diagnostics) products.
  • Familiarity with Agile PLM.

Ideal Candidate
Hands-on, execution-focused quality professional with strong problem-solving skills and the ability to work independently and cross-functionally in a regulated manufacturing environment.
Thanks & Regards,
Mahalakshmi

Junior Recruiter
Intellectt Inc 
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381