Senior QMS Specialist

Katalyst-Healthcares-; Utah; Sur place; USD 85 000 - 115 000; Plein temps

Résumé du poste

JobDiva, Inc. in Utah seeks a Senior Quality Systems Specialist – Medical Devices (QMS) to support quality management, CAPA remediation, spreadsheet validation, CSV validation, and regulatory compliance in a controlled environment.

The ideal candidate has strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk management, change control, document control, and validation processes, and can coordinate cross-functional teams to ensure timely closure of actions.

Qualifications

• 4–6 years of relevant experience in Medical Device Quality or related areas.
• Demonstrated experience working within a regulated medical device QMS environment.
• Experience with CAPA remediation, spreadsheet/software validation, CSV, risk management, change control, and document control.
• Experience preparing validation and quality documentation and supporting audit/compliance activities.
• Strong experience working with cross-functional teams in a global environment.
• Experience with electronic QMS systems, preferably Greenlight Guru or an equivalent platform.

Responsabilités

• Review spreadsheet inventories and assess validation requirements in accordance with procedures and quality standards.
• Develop, maintain, and review spreadsheet validation documentation, including Validation Plans, Validation Reports, Risk Assessments, Traceability Matrices, and Impact Assessments.
• Verify spreadsheet controls, formula integrity, access restrictions, document control requirements, and compliance with approved validation procedures.
• Support CAPA corrective action implementation and closure, particularly activities related to spreadsheet remediation and validation.
• Support alignment of local procedures with global requirements for software and spreadsheet validation, change control, and quality system processes.
• Prepare, review, and update controlled SOPs, forms, templates, work instructions, and quality records.
• Conduct gap assessments, risk assessments, and impact analyses to identify compliance issues and recommend corrective actions.
• Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
• Track project milestones, deliverables, risks, issues, and dependencies and provide regular status updates to project leadership.
• Prepare and maintain CAPA implementation evidence and audit-ready documentation packages.
• Support development of Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages.
• Participate in internal audits, compliance assessments, management reviews, and quality system remediation activities.
• Support continuous improvement initiatives to strengthen QMS processes, validation compliance, and regulatory readiness.
• Ensure all deliverables are completed in accordance with applicable company procedures, quality requirements, and project timelines.

Connaissances

Spreadsheet validation

CAPA remediation

Risk management

Change control

Document control

Software validation

QMS knowledge

Regulatory compliance

Outils

Greenlight Guru

Description du poste

Summary :

We are seeking a Senior Quality Systems Specialist – Medical Devices (QMS) to support Quality Management System, CAPA remediation, spreadsheet validation, software/Computer System Validation (CSV), and regulatory compliance activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk management, CAPA, change control, document control, and validation processes.

Roles & Responsibilities :

• Review spreadsheet inventories and assess validation requirements in accordance with applicable procedures and quality standards.
• Develop, maintain, and review spreadsheet validation documentation, including Validation Plans, Validation Reports, Risk Assessments, Traceability Matrices, and Impact Assessments.
• Verify spreadsheet controls, formula integrity, access restrictions, document control requirements, and compliance with approved validation procedures.
• Support CAPA corrective action implementation and closure, particularly activities related to spreadsheet remediation and validation.
• Support alignment of local procedures with global requirements for software and spreadsheet validation, change control, and quality system processes.
• Prepare, review, and update controlled SOPs, forms, templates, work instructions, and quality records.
• Conduct gap assessments, risk assessments, and impact analyses to identify compliance issues and recommend corrective actions.
• Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
• Track project milestones, deliverables, risks, issues, and dependencies and provide regular status updates to project leadership.
• Prepare and maintain CAPA implementation evidence and audit-ready documentation packages.
• Support development of Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages.
• Participate in internal audits, compliance assessments, management reviews, and quality system remediation activities.
• Support continuous improvement initiatives to strengthen QMS processes, validation compliance, and regulatory readiness.
• Ensure all deliverables are completed in accordance with applicable company procedures, quality requirements, and project timelines.

Required Experience :

• 4–6 years of relevant experience in Medical Device Quality, Quality Systems, Quality Assurance, Validation, or Regulatory Compliance.
• Demonstrated experience working within a regulated medical device QMS environment.
• Experience with CAPA remediation, spreadsheet/software validation, CSV, risk management, change control, and document control.
• Experience preparing validation and quality documentation and supporting audit/compliance activities.
• Strong experience working with cross-functional teams in a global environment.
• Experience with electronic QMS systems, preferably Greenlight Guru or an equivalent platform.