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Medical Device Risk Management Jobs in Rowlett, TX

10351

Senior Counsel, Medical Risk Management

Dallas, TX

$138K - $187K/yr

Reporting directly to the Assistant Vice President and Deputy General Counsel Medical Risk Management, this attorney-leader is also responsible for case assessment and favorably resolving complaints ...

OMS MEDICAL BILLING LLC

Risk Manager

Addison, TX · On-site

$50K/yr

Claims Management: Coordinate with insurance carriers and legal counsel on malpractice claims ... Risk Assessment: Conduct regular risk assessments of clinical practices, procedures, and protocols ...

Armavel, LLC

Cybersecurity Risk Analyst (REMOTE)

Dallas, TX · Remote

$90K - $100K/yr

... medical devices and Special Purpose Systems (e.g., building automation systems, physical security ... The analyst works within a Risk Management team and is expected to collaborate with Federal and ...

Sun Holdings

Risk Manager

Dallas, TX

Develop and implement company-wide risk management strategies and loss prevention initiatives ... Medical, Dental & Vision Insurance * 401(k) with Company Match * Paid Time Off * Company Paid Life ...

Sun Holdings

Risk Manager

Farmers Branch, TX

Develop and implement company-wide risk management strategies and loss prevention initiatives ... Medical, Dental & Vision Insurance * 401(k) with Company Match * Paid Time Off * Company Paid Life ...

CEDENT

Regulatory Affairs Specialist III

Plano, TX · On-site

... medical device product life cycle and regulatory requirements. In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR. Knowledge of ISO 14971 risk management for ...

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Showing results 21-40

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Rowlett, TX

Medical Device Risk Management information

See Rowlett, TX salary details

$46.2K

$100.1K

$152.5K

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

As of Aug 15, 2026, the average yearly pay for medical device risk management in Rowlett, TX is $100,091.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,800.00 and $115,700.00 per year, depending on experience, location, and employer.

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 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 job categories do people searching Medical Device Risk Management jobs in Rowlett, TX look for?

The top searched job categories for Medical Device Risk Management jobs in Rowlett, TX are:

What cities near Rowlett, TX are hiring for Medical Device Risk Management jobs?

Cities near Rowlett, TX with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Rowlett, TX as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $100,091 per year, or $48.1 per hour.

Quality Engineering Manager

Quest Medical, Inc.

Allen, TX • On-site

Full-time

Re-posted 20 days ago

Job description

JD534-016:
Position:
Manager, Quality Engineering
Department:
Reports To:
Vice President, Quality Assurance & Regulatory Affairs
FLSA Status:
JD Number:
JD534-016
Revision:
A
Summary:
Manages the Quality Engineering team to support new product development, process quality, CAPA, post-market compliance, supplier management, project management, internal & external auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA).
General Duties and Responsibilities:
  • Ensure the ongoing integrity, adequacy, and appropriateness of the Quality Management System and associated processes.
  • Provide technical support, leadership and quality guidance to multi-functional teams, including Quality, Regulatory, R&D, Operations, Engineering, and Marketing.
  • Select, develop, and evaluate Quality Engineering staff to support all aspects of design and manufacturing quality.
  • Act as assistant to the Management Representative during regulatory and customer audits.
  • Develop and implement and improve efficient quality systems processes.
  • Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization.
  • Establish and maintain quality metrics and utilizes KPIs to drive improvements.
  • Manage the CAPA program (to include Complaints, SCARs, NCMRs, Audit Non-Conformances and Corrective & Preventive Action projects). Ensure thorough investigations and implement effective corrective actions to prevent recurring issues.
  • Utilize root cause analysis and statistical techniques for complex problem solving of technical product and manufacturing issues.
  • Ensure a high level of supplier quality through effective supplier evaluation, approval, and monitoring processes. Collaborate with internal supply chain and external suppliers to drive continual improvement of supplier quality.
  • Develop and maintain FMEAs, Controls Plans, and SOPs to identify and mitigate risks.
  • Support the development and validation of new products and production lines.
  • Write, review, and approve documents (SOPs, Protocols, Reports, and ECOs) pertaining to key quality system elements affecting product quality.
  • Apply basic risk management principles to all aspects of the quality system.

Qualifications:
Required
  • Technical Engineering or Science degree at the Bachelor level or above.
  • 8+ years of quality engineering experience in a highly regulated industry.
  • 3+ years managing team members with varied backgrounds, experience, and technical capabilities.
  • Excellent working knowledge of medical device regulations and industry standards pertaining to manufacturing (FDA 21 CFR Part 820, ISO 13485, EU MDR (2017/745), the Medical Device Single Audit Program (MDSAP), and ISO 14971), IEC 60601..
  • Demonstrated project management skills, including the ability to prioritize and manage multiple project workloads in a highly dynamic production environment.
  • Solid working background utilizing quality management methods and tools (CAPA, Root Cause Analysis, FMEA, Control Plans, Statistical Techniques, MSA, etc.)
  • Demonstrated experience using trending and analysis reporting to drive organizational improvements.
  • Ability to develop and deliver clear communications (written and verbal), ensuring timely and relevant communication.
  • Some travel, domestic or international, may be required (up to 25%).

Preferred
  • ASQ Certified Quality Manager or Certified Quality Engineer
  • ISO 13485 Lead Auditor
  • Lean Six Sigma Green Belt or Black Belt
  • Working knowledge of IEC 60601 and IEC 62366
  • Experience with sterile product assembly and packaging
  • Experience with electronics assembly

Approvals:
Employee
Date
Department Head
Date

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