F

Fortive

Makes industrial tools and healthcare systems

Quality Systems Administrator

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeEverett, WA, USANo salary listedIn-person

About the Job

Requirements

  • An associate's degree in Business Administration, Quality, or Engineering is required.
  • A Certified Document Controller (CDC), Document Management Certified Professional (DMCP), or equivalent credential is required.
  • At least 3 years of experience in ISO-based quality systems administration, document control, quality assurance, or regulated business processes is required.
  • Understanding of ISO-based Quality Management Systems and quality support processes, including auditing, nonconformity and corrective action, control of documented information, and continual improvement is required.
  • Familiarity with ISO 9001, ISO 14001, and ISO 45001 is required.
  • Understanding of the fundamentals of Root Cause Corrective Action (RCCA) is required.
  • Experience managing records, documents, and workflow approvals is required.
  • Proficiency in Microsoft Office and Oracle PLM is required.

Responsibilities

  • Administer and coordinate Fluke's Global ISO 9001 Quality Management System processes, including internal audit programs, nonconformance and corrective action workflows, document control activities, management system records, and quality system activities within Product Lifecycle Management (PLM) and other business systems.
  • Coordinate the Global Internal Audit Program, including audit schedules, logistics, communications with third-party internal audit service providers, and scheduling opening meetings, closing meetings, and audit interviews with process owners and functional leaders.
  • Maintain annual audit schedules and calendars, track audit completion, and ensure audit reports are received and distributed appropriately.
  • Monitor audit findings and facilitate timely assignment of corrective actions and follow-up activities; prepare audit metrics and status reports for Quality leadership and management review activities as applicable.
  • Coordinate administrative activities associated with quality nonconformances, audit findings, problem reports, corrective actions, and preventive actions, and maintain accurate records within PLM and associated quality systems.
  • Monitor open corrective actions and escalation timelines, initiate and lead follow-up communications with responsible owners regarding overdue actions, and support root cause and corrective action workflow administration and reporting.
  • Generate dashboards and periodic reports on aging, closure rates, and quality system performance metrics; support preparation of management review inputs related to corrective action effectiveness and system performance.
  • Administer document control processes within PLM, managing document review, approval, revision, release, and archival workflows.
  • Ensure documents are reviewed and approved before scheduled expiration dates; coordinate routing with process owners, approvers, and subject matter experts; and maintain document control records and audit trails.
  • Support implementation and maintenance of document naming conventions, templates, and document governance requirements, and ensure controlled documents are current and accessible to appropriate users.
  • Serve as a system administrator and super-user for quality management system workflows within PLM; maintain quality records and management system documentation in accordance with established procedures.
  • Support user access requests, workflow troubleshooting, and system-related inquiries; assist in testing and deploying PLM workflow enhancements and process improvements.
  • Generate reports and metrics supporting Quality Management System performance monitoring, and support internal and external audits by retrieving and organizing quality records and documented information.
  • Support maintenance of records associated with ISO 9001, ISO 14001, and ISO 45001 management systems, including records related to audits, corrective actions, nonconformances, and documented information.
  • Support Quality leadership initiatives related to process improvement and management system effectiveness, as applicable.

About the Company

Fortive

Makes industrial tools and healthcare systems

Fortive makes measurement instruments, workplace safety systems and healthcare equipment for industrial technicians, facility managers and hospitals. Its operating companies include Fluke, whose test tools support electrical maintenance, and Advanced Sterilization Products, which builds systems for sterilizing medical instruments. Its software tracks assets and clinical workflows, while its hardware measures equipment conditions and protects workers; customers pay for instruments, consumables, services and software subscriptions. Founded as an independent company in 2016 after separating from Danaher, Fortive is headquartered in Everett, Washington.

Company size
10,001+
Company stage
IPO
Headquarters
Everett, WA
Founded
2016

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