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Quality Manager Medical Device Jobs (NOW HIRING)

Kellton Tech

Medical Device Technician

Madison, WI · On-site

$38.80K - $48.90K/yr

Ensure work is completed in compliance with company quality system and medical device regulations. Essential Functions * Assemble, test, and repair work per established work instructions, policies ...

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How much do quality manager medical device jobs pay per year?

As of Jun 1, 2026, the average yearly pay for quality manager medical device in the United States is $86,159.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $136,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Quality Manager in the Medical Device industry, and why are they important?

To thrive as a Quality Manager in the Medical Device industry, you need a solid background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and process improvement, often supported by a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), risk management tools (like FMEA), and certifications such as ASQ Certified Quality Auditor (CQA) or Six Sigma are typically required. Strong leadership, attention to detail, and effective communication are vital soft skills for managing teams and ensuring cross-functional alignment. These skills and qualifications are crucial to ensure product safety, regulatory compliance, and the overall success of medical device manufacturing and delivery.

What are some common challenges Quality Managers face when ensuring compliance in the medical device industry?

Quality Managers in the medical device industry often encounter challenges such as keeping up with evolving regulatory requirements (like FDA, ISO 13485, and MDR), coordinating cross-functional teams to maintain strict quality standards, and managing documentation for audits. They must also address nonconformities quickly and implement corrective and preventive actions to avoid product recalls. Effective communication and strong attention to detail are essential for navigating these challenges while maintaining product safety and regulatory compliance.

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

A Quality Manager in the medical device industry is responsible for ensuring that products meet all regulatory requirements and quality standards throughout their lifecycle. They develop, implement, and monitor quality management systems, oversee internal and external audits, and work closely with manufacturing, engineering, and regulatory teams to maintain compliance with standards such as ISO 13485 and FDA regulations. Their role is critical to ensuring patient safety and product efficacy by preventing defects and ensuring consistent quality.

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

AspectQuality Manager Medical DeviceQuality Engineer Medical Device
Primary FocusOversees quality systems, compliance, and team managementDesigns, develops, and implements quality testing and inspection processes
CertificationsISO 13485, Six Sigma, Lead AuditorISO 13485, Six Sigma, Certified Quality Engineer (CQE)
Work EnvironmentManagement, regulatory compliance, cross-department collaborationProduct testing, process improvement, technical analysis
Industry UsageUsed across organizations to ensure overall quality managementUsed in product development and testing phases

The main difference is that the Quality Manager Medical Device focuses on managing quality systems and compliance at a strategic level, while the Quality Engineer Medical Device concentrates on technical testing and process improvements. Both roles require similar certifications and work within the same industry but serve different functions within quality assurance.

More about Quality Manager Medical Device jobs
What cities are hiring for Quality Manager Medical Device jobs? Cities with the most Quality Manager Medical Device job openings:
What are the most commonly searched types of Quality Medical Device jobs? The most popular types of Quality Medical Device jobs are:
What states have the most Quality Manager Medical Device jobs? States with the most job openings for Quality Manager Medical Device jobs include:
What job categories do people searching Quality Manager Medical Device jobs look for? The top searched job categories for Quality Manager Medical Device jobs are:
Quality Manager Medical Device jobs near you
Infographic showing various Quality Manager Medical Device job openings in the United States as of May 2026, with employment types broken down into 83% Full Time, and 17% Part Time. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $86,159 per year, or $41.4 per hour.

Quality Engineer (Medical Device, Pharmaceutical)

eQuest Solutions

Denver, CO • Hybrid

$74.10K - $95.70K/yr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 22 days ago

Job description

Please note I have direct access to the Hiring Director on this position. Compensation: Base Salary + Bonus: 10% + Relocation Assistance

We are the leading Global Biotech Company in our niche and are looking for a Quality Engineer. We have been in business for 50+ years, are publicly traded, have 7+K global employees, recognized $6.6 billion in revenues (7% increase over previous year), $153 million in profits (32% increase over previous year), have 750+ product patents, released 6 new products in in the past year and are an active philanthropic institution.

This role functions as a hybrid Quality Engineer and SAP Business Analyst, specifically focused on the quality elements and regulatory integrity of the ERP system. The candidate will not perform technical configurations but must possess a deep functional understanding of how medical devices move through SAP, specifically within Supply Chain and Finance workstreams. Coming from a Quality Department background in a regulated environment, this individual will ensure that system workflows for CAPA, batch records, and engineering changes remain compliant with global medical device regulations.

Responsibilities:

  • Provide regulatory compliance support by ensuring all SAP processes and system documentation align with FDA, ISO 13485, and other global medical device standards.
  • Manage engineering change workflows and technical documentation within SAP, maintaining strict consistency and traceability across all internal departments.
  • Oversee the quality elements of the system, including the management of CAPA (Corrective and Preventive Actions) and the movement of electronic batch records through the system.
  • Partner with Process Engineering, Finance, Regulatory, and Operations teams to align SAP system capabilities with evolving business needs and technical requirements.
  • Apply established Quality Engineering principles to enhance SAP workflows that support product design, validation, and manufacturing processes.
  • Identify and implement continuous improvements to SAP workflows to drive efficiency, compliance, and an improved user experience.
  • Develop detailed user specifications and write requirements for how processes should function within the ERP environment.
  • Analyze and document how various SAP modules interact, focusing on the integration between Supply Chain and Finance.

Requirements:

  • Professional background within a Quality Department of a medical device or pharmaceutical company is highly preferred.
  • Deep understanding of medical device regulations (FDA 21 CFR Part 820, ISO 13485) and their application within an automated system.
  • Strong knowledge of ERP systems (SAP preferred) with the ability to map the physical movement of goods to digital system transactions.
  • Functional expertise in Supply Chain and Finance modules, including an understanding of how these workstreams intersect in a manufacturing environment.
  • Demonstrated ability to develop user specifications, workstream documentation, and process requirements.
  • Experience managing technical documentation and engineering change control processes.
  • Strong collaborative skills to work across Process Engineering, Finance, and Regulatory teams.
  • Experience in any of the following are only a Plus; NOT mandatory Prior experience participating in or completing a full-lifecycle SAP implementation and reporting experience with Custom SQL, Power BI, Magnitude Angles (Every Angle), etc..

Benefits

Company offers a comprehensive benefits package including: 6% matching 401K (immediately vested); 5 Weeks PTO, HMO/PPO Medical, Dental, and Vision coverage for employees; paid company holidays, flexible spending plans/HSA, tuition reimbursement and a casual work environment.

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