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Medical Device Risk Management Jobs in Fort Mill, SC

Aptyx

R&D Project Manager

Charlotte, NC · On-site

$90K - $150K/yr

Risk Management & Problem SolvingIdentify and proactively manage risks related to scope, schedule ... medical device development strongly preferred Strong knowledge of design controls and regulated ...

Aptyx

Transfer Engineer I-II

Charlotte, NC · On-site

$60K - $95K/yr

Ensure compliance with medical device regulations and internal validation standards. Process ... Validation & Risk ManagementContribute to (I) and independently plan/execute (II) validation ...

First Horizon Bank

Risk Consultant

Charlotte, NC · On-site

Support Risk Analytics processes including earnings reporting, management reporting, and ad hoc ... Benefit Highlights • Medical with wellness incentives, dental, and vision • HSA with company ...

Honeywell

Sr Manager Risk and Resilience

Charlotte, NC · On-site

Qualifications YOU MUST HAVE * 5+ years proven experience in business continuity management ... This package includes employer subsidized Medical, Dental, Vision, and Life Insurance; Short-Term ...

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Showing results 41-60

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Fort Mill, SC

Medical Device Risk Management information

See Fort Mill, SC salary details

$45.3K

$98K

$149.4K

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

As of Aug 17, 2026, the average yearly pay for medical device risk management in Fort Mill, SC is $98,030.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,100.00 and $113,400.00 per year, depending on experience, location, and employer.

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 are popular job titles related to Medical Device Risk Management jobs in Fort Mill, SC?

For Medical Device Risk Management jobs in Fort Mill, SC, the most frequently searched job titles are:

Medical Device Risk Management jobs near you

Senior Metrology or Calibration Engineer (Contract)

VTI Life Sciences

Charlotte, NC • On-site

Contractor

Posted 20 days ago

Job description

Location: Onsite for initial project Audit/GAP Analysis and Remote for summary reports with periodic on-site travel (as required).
Duration: Approximately 6 weeks (potential for extension)
Client: Confidential Pharmaceutical / Medical Device Company
Position Summary
VTI Life Sciences is seeking an experienced Senior Metrology or Calibration Specialist to support a comprehensive Quality Control (QC) and Equipment Metrology Program assessment for a regulated pharmaceutical and medical device manufacturing facility. The successful candidate will evaluate the overall health of the metrology program by validating approximately 600 metrology assets and associated records, identifying compliance gaps, assessing instrument performance risks, and recommending improvements to strengthen regulatory compliance and audit readiness.
In addition to the assessment, the candidate will provide technical support for equipment decommissioning, installation, calibration, and integration of critical laboratory and manufacturing equipment into the site's metrology program.
Key Responsibilities
  • Perform a comprehensive assessment of the site's Metrology Program.
  • Review and validate approximately 600 metrology assets, including laboratory instruments, timers, thermometers, balances, gauges, pressure and temperature devices, and other calibrated equipment.
  • Evaluate calibration records, maintenance history, asset identification, calibration intervals, traceability, and documentation for compliance with GMP and internal procedures.
  • Assess metrology program effectiveness, identify gaps, and recommend corrective and preventive actions (CAPAs).
  • Evaluate known instrument performance risks and recommend improvements to increase equipment reliability and audit readiness.
  • Support equipment decommissioning activities, ensuring proper documentation, asset disposition, and quality system compliance.
  • Provide technical oversight for installation, calibration, and commissioning support of critical laboratory and process equipment.
  • Review calibration procedures and recommend improvements where appropriate.
  • Verify traceability to NIST (or equivalent national standards), uncertainty considerations, and calibration best practices.
  • Prepare detailed assessment reports, observations, risk assessments, and executive summaries.
  • Collaborate with Quality Assurance, Engineering, Validation, Manufacturing, and Laboratory personnel to resolve metrology issues.
  • Support regulatory inspection readiness and internal audit preparation.
Required Qualifications
  • Bachelor's or Associate  (certification) degree in Engineering, Physics, Metrology, Instrumentation, Engineering Technology, or a related scientific discipline.
  • Minimum 7 years of metrology, calibration, or instrumentation experience in FDA-regulated pharmaceutical, biotechnology, medical device, or life sciences industries.
  • Extensive knowledge of GMP requirements and calibration program management.
  • Strong understanding of FDA 21 CFR Parts 210, 211, and 820 (QMSR), ISO 13485, ISO/IEC 17025, and applicable industry standards.
  • Experience assessing large calibration programs involving hundreds of assets.
  • Plus if experience with computerized calibration management systems (e.g., Blue Mountain RAM, Beamex CMX, IndySoft, GAGEtrak, Maximo, SAP PM, or equivalent).
  • Strong understanding of calibration uncertainty, traceability, and measurement science.
  • Excellent technical writing, documentation, and communication skills.
Preferred Qualifications
  • ASQ Certified Calibration Technician (CCT) or equivalent certification.
  • Experience supporting FDA inspections and regulatory audits.
  • Experience performing gap assessments and remediation projects.
  • Familiarity with commissioning, qualification (IQ/OQ/PQ), and equipment lifecycle management.
  • Experience with laboratory and manufacturing instrumentation in pharmaceutical or medical device facilities.
Deliverables
  • Comprehensive QC Metrology Program Assessment Report.
  • Asset-by-asset validation summary and compliance review.
  • Gap assessment with risk ranking and recommended corrective actions.
  • Equipment decommissioning documentation support.
  • Installation and calibration support for critical equipment.
  • Executive summary with prioritized recommendations to improve compliance, reliability, and audit readiness.
Desired Skills
  • Strong analytical and problem-solving abilities.
  • Excellent organizational and project management skills.
  • Ability to work independently with minimal supervision.
  • Strong interpersonal skills with the ability to communicate effectively with cross-functional teams and client stakeholders.
  • Ability to prioritize multiple tasks while meeting aggressive project timelines.

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