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Senior Quality Engineer Medical Device Jobs (NOW HIRING)

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? • ...

Permobil

Senior Quality Engineer

New Berlin, WI · On-site

$86K - $117K/yr

Sr. Quality Engineer New Berlin, WI Position Summary: Sr. Quality Engineer, New Berlin, WI. Provide ... medical device design and development. How to Apply: Apply with Permobil, Inc. online at

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

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

Cypress HCM

Senior Quality Engineer

New Hope, MN

$91K - $124K/yr

This Sr Quality Engineer is primarily responsible for providing technical support to ensure ... Previous experience with Class II or Class III medical device contract manufacturing complex ...

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Senior Quality Engineer Medical Device information

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

As of Jun 11, 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.
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Senior Quality Engineer Medical Device jobs near you

Sr. Quality Engineer - Medical Device Manufacturing

MICRON PRODUCTS INC & SUBSIDIARIES

Fitchburg, MA

$89K - $121K/yr

Full-time

Medical, Retirement, PTO

Posted 20 days ago

Job description

Micron Solutions is a multifaceted contract manufacturing organization specializing in thermoplastic injection molding, precision machining and finishing, and silver-plated medical sensors for disposable electrodes. We collaborate with clients of all sizes to provide manufacturing solutions and assembly services that support their goals from concept to commercialization. Our 120,000 square foot Fitchburg, MA facility is equipped to manage projects across the full product lifecycle.

The Senior Quality Engineer ensures compliance with FDA regulations, ISO 13485 standards, and customer requirements for the manufacturing and assembly of molded and machined components, including medical device components and assemblies. This role is responsible for maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting product quality throughout the lifecycle. The engineer serves as a technical expert in risk management, process controls, and regulatory compliance.

What We Offer:

  • Competitive salary 
  • Comprehensive benefits package, including health insurance, 401(k), and paid time off.

KEY ACCOUNTABILITIES

Regulatory & Quality Compliance

  • Maintain and enhance QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
  • Lead internal, customer, and regulatory audit activities,; including preparation and response..
  • Ensure adherence to Good Manufacturing Practices (GMP) and risk-based quality approaches.

Process & Product Quality

  • Develop and implement quality plans, inspection methods, and control plans for medical device components.
  • Lead root cause analysis and corrective/preventative actions (CAPA) for nonconformances and complaints.
  • Collaborate with engineering and production teams on new product launch introductions, including process validation (IQ/OQ/PQ) and equipment qualification.

Risk Management & Documentation

  • Conduct risk assessments per ISO 14971 and maintain risk files.
  • Prepare and maintain quality documentation, including Device History Records (DHR), validation reports, and audit findings.
  • Ensure proper document control and traceability for all components and assemblies.

Continuous Improvement

  • Drive initiatives using Lean, Six Sigma, and statistical methods to reduce defects and improve yield.
  • Analyze quality metrics (scrap, rework, complaints) and implement corrective actions.

Customer & Supplier Interface

  • Serve as primary quality contact for medical device OEM customers, addressing concerns and ensuring satisfaction.
  • Support supplier quality activities, including qualification, audits, and performance monitoring.

JOB QUALIFICATIONS

Education:

Bachelor’s degree in Engineering (Mechanical or Industrial preferred)

Experience:

  • Minimum 7+ years in quality engineering within medical device manufacturing or assembly
  • Strong knowledge of ISO 13485, FDA QMSR, and risk management principles

Skills:

  • Proficiency in lean principles and continuous improvement methodologies.
  • Strong computer  skills ( MS Office, ERP systems, electronic QMS systems).
  • Expertise in quality tools: Root Cause Analysis, SPC, FMEA, MSA, GD&T.
  • Experience with metrology, process validation and statistical analysis
  • Excellent problem-solving, analytical, organizational and communication skills.

Preferred Certifications

  • ASQ Certified Quality Engineer (CQE)
  • Six Sigma Green/Black Belt

Core Competencies

  • Leadership and team collaboration
  • Strong attention to detail and compliance
  • Continuous improvement mindset
  • Ability to manage multiple priorities independently in a regulated environment

Please note: This position is not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship requirements.

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