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Medical Device Risk Management Jobs in Texas (NOW HIRING)

Spectral MD Inc

Cybersecurity Engineer

Dallas, TX · On-site

Cybersecurity Risk Management * Perform cybersecurity risk assessments for medical device systems using structured methodologies (Threat Modeling, STRIDE, DREAD, Attack Trees, SBOM analysis)

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Texas

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 9, 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:
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Medical Device Risk Management jobs near you
Sr. Manager - Quality Assurance

Sr. Manager - Quality Assurance

Quest Medical, Inc.

Allen, TX • On-site

Full-time

Retirement, PTO

Posted 20 days ago

Job description

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.
Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
Summary:
The Sr. Manager of Quality Assurance leads the Quality Operations and Quality Engineering teams to ensure exceptional product quality and regulatory compliance. This role involves strategic project management to balance multiple projects with competing priorities. Key responsibilities include developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, and validating test methods. The manager reviews and approves critical documents such as Device History Records, SOPs, Validation Protocols, Deviation Reports, and CAPA Reports to ensure operational support and compliance.
Additionally, the Sr. Quality Assurance Manager manages environmental monitoring in production areas, oversees sterilization validation activities, and leads root cause analysis investigations for effective CAPA resolution. The role also involves qualifying and monitoring suppliers, deploying risk mitigations to ensure product safety, and participating in regulatory inspections and customer audits. Continuous innovation and improvement of testing methods and processes are essential aspects of this position.
General Duties and Responsibilities:
  • Manages and develops the Quality Operations and Quality Engineering leadership staff.
  • Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization
  • Develops effective Quality Control Plans to assure world-class product quality.
  • Utilizes data as related to the Quality Control and CAPA operations.
  • Develops and validates test methods, performs data analysis, and writes/revises SOPs.
  • Reviews and approves documents, including Device History Records, Standard Operating Procedures, Validation Protocols and Reports, Deviations, Engineering Change Requests, and Non-Conforming Materials Reports, CAPA Reports, Complaint investigations and Supplier Corrective Action Reports to ensure operational support and compliance.
  • Manages the environmental monitoring program in applicable production areas, including sterilization validation and re-validation activities.
  • Leads root cause and failure analysis investigations to ensure effective CAPA resolution.
  • Continuously innovate and improve methods and processes. Defines optimum approaches in testing and analyzing data for each test being performed.
  • Acts as assistant to Management Representative during customer and regulatory audits. Participates in regulatory inspections and customer audits.
  • Qualifies new suppliers as needed and perform routine supplier monitoring activities.
  • Deploys effective risk mitigations to assure product safety and efficacy.

Qualifications:
  • Bachelor's degree in a technical or scientific discipline is required.
  • A minimum of ten years of experience in a quality or regulatory position, preferably in the medical device industry. Experience with EO sterilization processes, sterile product assembly and packaging, and electronics assembly preferred.
  • A minimum of five years of management experience or 10 years in a quality leadership role.
  • Excellent working knowledge of the FDA's 21 CFR Part 820; ISO 13485; EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese MHLW Ordinance 169; RDC ANVISA 16/2013, Australian TG(MD)R, ISO 14971, ISO 9001, and Medical Device Single Audit Program (MDSAP). Experience with IEC 60601 preferred.
  • Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory requirements.
  • Detail oriented and possess a professional demeanor, be adaptable to changing environments, handle diverse workloads, and capable of completing tasks with little or no supervision.
  • Demonstrated ability to work in a highly cross-functional environment.
  • Excellent technical writing experience within a medical device environment is essential.
  • Strong root cause analysis skills.
  • Ability to use sound scientific judgement and risk management for the facility to prevent regulatory action.
  • The ability to work with minimal supervision to prioritize tasks and be able to manage several projects and tasks simultaneously to meet deadlines; and the ability to interface with all levels of management.
  • Certified Lead Auditor or ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred.

Notables / Benefits:
  • Summer hours available
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation and other excellent benefits

An Equal Opportunity Employer

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