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Medical Device Risk Management Jobs in Texas (NOW HIRING)

Crown Medical, Inc.

Medical Device Sales Rep

Dallas, TX · On-site

$89K - $119K/yr

Medical Sales Territory Representative - We are a leading Medical Device and Equipment company ... Ability to effectively manage a physician-based customer base * Skills to communicate clinically ...

Revance

Project Manager, Medical Device

Dallas, TX · Remote

$8K - $105K/yr

... project management activities, including timeline development, milestone tracking, risk ... PMP certification and prior medical device experience are preferred. * Reporting to: Technical ...

Hendrick Health

Manager - Risk Management

Abilene, TX · On-site

The position reports to and supports the Hendrick Health Director of Risk Management by conducting ... Ability to navigate the electronic medical record (Allscripts/Apollo EMR) * Ability and interest to ...

Power Finance Texas

Risk Management Analyst

Dallas, TX · On-site

$70K - $85K/yr

Position Summary The Risk Management Analyst is responsible for identifying, assessing, and ... Medical, dental, and vision insurance * 401(k) with company match * Paid time off and company ...

Hendrick Health

Manager - Risk Management

Abilene, TX · On-site

The position reports to and supports the Hendrick Health Director of Risk Management by conducting ... Ability to navigate the electronic medical record (Allscripts/Apollo EMR) * Ability and interest to ...

Astura Medical

Medical Device Audit Inspector

Irving, TX · On-site

$20 - $21/hr

This position works from the direction of the Receiving Manager to process inventory. Your work ... Familiarity with medical device handling, sterilization, or reprocessing workflows * Strong ...

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Medical Device Risk Management information

See Texas salary details

$48K

$103.9K

$158.4K

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

As of Jun 6, 2026, the average yearly pay for medical device risk management in Texas is $103,932.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,800.00 and $120,200.00 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 are popular job titles related to Medical Device Risk Management jobs in Texas? For Medical Device Risk Management jobs in Texas, the most frequently searched job titles are:
What job categories do people searching Medical Device Risk Management jobs in Texas look for? The top searched job categories for Medical Device Risk Management jobs in Texas are:
What cities in Texas are hiring for Medical Device Risk Management jobs? Cities in Texas with the most Medical Device Risk Management job openings:
Medical Device Risk Management jobs near you

Regulatory & Quality Systems Consultant_Medical Devices

Volto USA

Austin, TX • On-site

Contractor

Posted 21 days ago

Job description

Key Responsibilities:
•       Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
•       Evaluate the medical device manufacturer’s Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
•       Conduct rigorous onsite or virtual stress-testing of core QMS processes:
o       Management Responsibility & Resource Management
o       Design and Development / Technical Documentation Files
o       Production and Service Provision (Cleanroom, Sterilization, Validation)
o       CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
•       Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
•       Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
•       Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
•       Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
•       Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.
Required Qualifications:
•       Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
•       Minimum 8 years of experience in the Medical Device industry, specifically in Quality Assurance or Regulatory Affairs.
•       Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
•       Proven track record of preparing medical device manufacturers for successful Notified Body audits, specifically with BSI.
•       Deep, current knowledge of ISO 13485:2016, ISO 14971 (Risk Management), and European medical device regulations.
•       Strong analytical, interviewing, and technical report-writing skills.
•       Ability to deliver objective, critical feedback constructively under tight preparation timelines.
Preferred Qualifications:
•       Former BSI Lead Auditor experience is highly preferred.
•       Hands-on experience managing a front-room/back-room during a live BSI QMS audit.
•       Experience auditing the specific device risk classification and technology relevant to our product portfolio.
•       Familiarity with MDSAP requirements.
Key Competencies:
•       BSI Audit Readiness & Notified Body Interface
•       Rigorous Gap Analysis & Nonconformance Classification
•       Risk-Based Auditing & Technical File Evaluation
•       SME Coaching & Interview Preparation
•       Objective, High-Pressure Stakeholder Communication