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Medical Device Risk Management Jobs in Missouri (NOW HIRING)

kindeva

Senior Device Engineer

Maryland Heights, MO · On-site

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

ArchKey Solutions

Risk Management Specialist

Fenton, MO · On-site

RISK MANAGEMENT SPECIALIST This position is based out of our St Louis, MO office About the company ... medical, dental, and vision), a robust 401(k) retirement savings plan with employer match, paid ...

ArchKey Solutions

Risk Management Specialist

Fenton, MO · On-site

RISK MANAGEMENT SPECIALIST This position is based out of our St Louis, MO office About the company ... medical, dental, and vision), a robust 401(k) retirement savings plan with employer match, paid ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Missouri

Medical Device Risk Management information

See Missouri salary details

$48.3K

$104.6K

$159.5K

How much do medical device risk management jobs pay per year?

As of Jul 26, 2026, the average yearly pay for medical device risk management in Missouri is $104,640.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,400.00 and $121,000.00 per year, depending on experience, location, and employer.

Is risk management a good career?

Risk management in the medical device industry involves identifying and mitigating potential safety and compliance issues, which is essential for product development and regulatory approval. It requires strong analytical skills, knowledge of standards like ISO 14971, and often involves collaboration with engineering and quality teams. The field offers opportunities for growth, specialization, and a stable career path due to the importance of safety in healthcare products.

What is the highest paying risk management job?

In the field of medical device risk management, senior roles such as Risk Management Directors or Chief Risk Officers typically have the highest salaries, often exceeding six figures. These positions require extensive experience, certifications like ISO 14971, and leadership skills, reflecting their strategic importance and responsibility within organizations.

How much does a risk manager get paid?

A medical device risk management professional's salary typically ranges from $70,000 to $130,000 annually, depending on experience, certifications, and location. Senior risk managers or those with specialized skills can earn higher salaries, especially in regulated environments requiring knowledge of ISO 14971 and risk assessment tools.

What are the key skills and qualifications needed to thrive in Medical Device Risk Management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What is risk management in the medical device industry?

Risk management in medical device risk management involves identifying, assessing, and controlling potential hazards associated with medical devices to ensure patient safety and regulatory compliance. Professionals in this field use tools like risk analysis and failure mode effects analysis (FMEA) and often require knowledge of standards such as ISO 14971. Effective risk management is essential throughout the device lifecycle, from design to post-market surveillance.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a Medical Device Risk Management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.
What are popular job titles related to Medical Device Risk Management jobs in Missouri? For Medical Device Risk Management jobs in Missouri, the most frequently searched job titles are:
What job categories do people searching Medical Device Risk Management jobs in Missouri look for? The top searched job categories for Medical Device Risk Management jobs in Missouri are:
What cities in Missouri are hiring for Medical Device Risk Management jobs? Cities in Missouri with the most Medical Device Risk Management job openings:
Medical Device Risk Management jobs near you

Director, Quality Assurance - Medical Device Services (Multi-Site)

Eurofins USA Medical Devices

Maryland Heights, MO • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 6 days ago

Job description

Company Description

Reporting directly to the President, Medical Device Services, the Senior Director, Quality & Laboratory Excellence is a strategic leadership role responsible for defining and executing the Quality vision across Eurofins Medical Device Services in North America.

This position is far more than a traditional Quality Assurance leadership role. We are seeking an executive leader who can build a modern, scalable, risk-based Quality organization that enables rapid business growth while maintaining the highest standards of scientific integrity, laboratory excellence, regulatory compliance, and customer confidence.

The successful candidate will lead the transformation and harmonization of Quality Management Systems across a growing network of laboratories and consulting businesses while supporting acquisitions, new service offerings, laboratory expansions, and future growth into medical device product development and engineering services.

Working closely with the President the leadership team, this individual will position Quality as a strategic competitive advantage that enables innovation, operational excellence, and commercial success.

In addition to leading Quality for Medical Device Services, the Senior Director will serve as an active member of the North America Quality Leadership Team, collaborating with Quality leaders across the BioPharma Product Testing (BPT) and Medical Device Services (MDS) businesses to advance enterprise-wide Quality initiatives, share best practices, harmonize Quality systems where appropriate, and strengthen a consistent culture of Quality across laboratories and business segments while recognizing the unique regulatory requirements of each market.

Job Description

Quality Leadership & Governance

  • Provide strategic leadership for Quality Assurance activities across multiple Medical Device Services sites.
  • Develop, implement, and maintain a harmonized Quality Management System (QMS) aligned with corporate and regulatory requirements.
  • Establish quality objectives, key performance indicators (KPIs), and continuous improvement initiatives across all sites.
  • Foster a culture of quality, compliance, accountability, and customer focus.
  • Lead Management Review processes and communicate quality performance metrics to executive leadership.
  • Ensure effective escalation and resolution of significant quality and compliance issues.

Regulatory & Quality Compliance

Ensure compliance with applicable regulatory, accreditation, and quality standards, including:

  • ISO/IEC 17025
  • OECD Good Laboratory Practice (GLP) and FDA 21 CFR Part 58
  • FDA 21 CFR Part 11
  • FDA Quality Management System Regulation (QMSR) / 21 CFR Part 820, as applicable
  • ISO 13485, as applicable
  • Medical Device Single Audit Program (MDSAP), where applicable
  • European Union Medical Device Regulation (EU MDR), where applicable
  • Other applicable national and international regulatory and accreditation requirements

Lead Quality Systems supporting ISO/IEC 17025-accredited laboratories and GLP-compliant operations while ensuring appropriate application of QMSR and ISO 13485 requirements where applicable.
Monitor changes in regulatory, accreditation, and industry standards and ensure timely implementation across all Medical Device Services sites.
Serve as the executive Quality representative during regulatory inspections, accreditation assessments, customer audits, and corporate Quality reviews.
Ensure timely and sustainable resolution of compliance observations, audit findings, and regulatory commitments through effective corrective and preventive action.

Quality Systems Oversight

  • Provide oversight and approval for Quality Systems elements such as:
    • Deviations and quality events
    • CAPA investigations
    • Change controls
    • Risk assessments
    • Internal audits
    • Supplier qualification and monitoring programs
    • Training and qualification systems
    • Document control processes
  • Ensure effectiveness of quality systems through trending, monitoring, and management review activities.
  • Drive standardization and harmonization of procedures across all sites.

Audit & Inspection Management

  • Lead preparation and execution of:
    • FDA inspections
    • ISO and accreditation audits
    • Customer audits
    • Corporate quality audits
  • Ensure audit readiness across all locations.
  • Oversee responses to observations and ensure sustainable corrective actions are implemented.
  • Monitor inspection trends and proactively address systemic quality risks.

Continuous Improvement & Operational Excellence

  • Champion continuous improvement initiatives utilizing Lean, Six Sigma, risk-based quality management, and operational excellence principles.
  • Drive quality metric reviews and identify opportunities for process optimization.
  • Promote data-driven decision making and quality risk management practices.
  • Support business expansion, new service offerings, and site integration activities from a quality perspective.

Leadership & People Management

  • Lead and develop site QA Managers, Supervisors, and quality professionals.
  • Establish talent development, succession planning, and performance management processes.
  • Ensure appropriate staffing levels and resource allocation across sites.
  • Mentor quality leaders and support employee engagement initiatives.
  • Promote collaboration among Quality, Operations, Regulatory Affairs, Technical, and Client Services teams.

Technical Knowledge Requirements

Strong working knowledge of:

  • FDA 21 CFR Part 820
  • FDA 21 CFR Part 11
  • ISO 13485
  • ISO 17025
  • Medical Device Single Audit Program (MDSAP)
  • Risk Management principles (ISO 14971 preferred)
  • CAPA systems
  • Change Control systems
  • Internal Audit programs
  • Supplier Quality Management
  • Data Integrity requirements
  • Validation and Computer System Validation concepts
  • Statistical and trend analysis methodologies
  • Electronic Quality Management Systems (eQMS)
Qualifications

Education

  • Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, Medical Technology, Pharmaceutical Sciences, or related scientific discipline required.
  • Master's degree in Science, Engineering, Quality Systems, Regulatory Affairs, or Business Administration preferred.

Experience

  • Minimum 10–15 years of progressive experience in Quality Assurance, Regulatory Compliance, or Quality Systems within:
    • Medical Device Testing
    • Medical Device Manufacturing
    • Contract Research Organizations (CROs)
    • Contract Testing Laboratories
    • Healthcare or Life Sciences environments
  • Minimum 5 years of leadership experience managing Quality organizations.
  • Ability to travel up to 30–50% as required to support multiple domestic and international sites.
  • Demonstrated experience leading quality operations across multiple sites or business units.
  • Proven experience supporting FDA inspections, ISO audits, and customer audits.
  • Experience implementing and maintaining ISO 13485 and/or ISO 17025 compliant Quality Management Systems.

Additional Information

Eurofins offers a comprehensive benefits package including medical, dental, vision, life and disability insurance, 401(k) with company match, paid holidays, vacation, and opportunities for professional growth and development.

Eurofins USA Medical Devices is a Disabled and Veteran Equal Employment Opportunity employer.