ZipRecruiter

Log In

1

Medical Device Risk Management Jobs in West Virginia

ProPharma Group

Quality Specialist

Charleston, WV · On-site +1

... biotech, med device, and pharmaceutical organizations of all sizes to confidently advance ... Participate inGxPchange management activities including risk and impact analysis review, change ...

Becton, Dickinson and Company

... in Med Device or Life Sciences organizations. * Strong facilitation skills with proven ability to ... Curious and innovative, with the ability to push boundaries while navigating governance and risk.

Becton, Dickinson and Company

... Marketing, and Managed Markets byutilizingacademic credentials, clinical knowledge, and ... Knowledge of the US Healthcare System and the pharmaceutical/medical device industry, including ...

ProPharma Group

Research Assistant

Charleston, WV · On-site

$17.75 - $24.50/hr

... biotech, med device, and pharmaceutical organizations of all sizes to confidently advance ... Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the ...

previous page

Showing results 41-60

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in West Virginia

Medical Device Risk Management information

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 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 job categories do people searching Medical Device Risk Management jobs in West Virginia look for?

The top searched job categories for Medical Device Risk Management jobs in West Virginia are:

What cities in West Virginia are hiring for Medical Device Risk Management jobs?

Cities in West Virginia 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 West Virginia as of June 2026, with employment types broken down into 1% As Needed, 89% Full Time, 1% Part Time, 1% Temporary, and 8% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Quality Specialist

Charleston, WV • On-site, Remote

ProPharma Group
Business Management Consulting • 51 - 200 employees
Learn more about ProPharma Groupexternal

Full-time

Posted 17 days ago

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Essential Functions:

  • Maintain awareness of, and ensure compliance with, theGxPguidelines and regulations relevant to the services provided.

  • Supports and facilitates eQMS activities (i.e., Change Control, Deviations, Quality Events (QEs), CAPAs, Effectiveness Checks, etc.)

  • Develop, recommend, andmonitorDeviations,QEsand CAPAs. Review, approve, and communicate root cause and CAPAs to stakeholders.

  • Perform effectiveness checks on Deviations and QEs todetermineefficacy of CAPAs.

  • Participate inGxPchange management activities including risk and impact analysis review, change plan review and approval, action plan implementation, andtracking tocompletion, as applicable.

  • Support client audits and regulatory inspections processes (including questionnaires):

  • Coordinate and finalization of agenda, document provision; ensuring internallogisticsand Subject Matter Expert (SME) are in place.

  • Coordinate and manage audit CAPA responses including developing responses to CAPAs with support from relevant internal SMEs.

  • Track audit and inspection records in eQMS to closure.

  • Ensuring audit information ismaintainedand stored in eQMS.

  • Generates and prepares reports to communicate outcomes of quality activities.

  • Analyzes and investigates Deviations and QEs toidentifyareas for improvement in the quality system.

  • Collection, management, and analysis of data related to CAPAs, Deviations, QEs, and quality KPIs.

  • Medical Informationspecific:

  • Retrospectively evaluates telephone skills and case reports to ensure compliance standards are met andmaintained.

  • Other duties as needed.

Necessary Skillsand Abilities:

  • Fluent in English speaking and writing.

  • Knowledge and experienceinworking with GXP Quality Management Systems.

  • Proficient computer skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

  • Exceptional organization, prioritization, projectmanagementand delegation skills; able to multitask.

  • Excellent attention to detail and focus on quality.

  • Excellent verbal, written, and interpersonal communication skills with the ability toestablishstrong professional relationships with quality and internal staff, and with clients.

  • Exceptional customer service skills within quality and internal staff, and with clients.

  • Ability to build positive collaborations with other departments and be open to change.

  • Works in a professional manner with clients, teammembersand management.

  • Flexible and proactive toward changing needs.

  • Proactive with the ability to work with minimal supervision.

#LI-JB1

#LI-REMOTE

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Apply