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jazzhr

Quality Manager

SoftWave TRT
Marietta, USA
Full-time
Senior Level
Onsite
Discovered 1 months ago

Full Job Posting

  • Own and maintain the company’s QMS in alignment with applicable medical device standards
  • Develop, implement, and maintain procedures, SOPs, work instructions, and quality records
  • Manage document control, revision control, and training documentation processes
  • Ensure continuous audit readiness across all quality system elements
  • Lead the Corrective and Preventive Action (CAPA) system
  • Ensure timely initiation, investigation, root cause analysis, and closure of CAPAs
  • Verify effectiveness of corrective actions
  • Drive cross-functional accountability for issue resolution and process improvement
  • Lead supplier qualification and quality oversight activities
  • Establish supplier quality agreements and quality performance metrics
  • Manage supplier corrective action requests (SCARs)
  • Conduct supplier quality reviews and support supplier audits
  • Partner with Supply Chain and Operations on supplier performance and issue resolution
  • Lead internal audit planning and execution
  • Serve as primary quality lead for external audits, customer audits, and certification audits
  • Coordinate responses to audit findings and corrective actions
  • Maintain audit schedules, records, and follow-up activities
  • Support Regulatory Affairs with submission documentation and compliance records
  • Maintain quality documentation required for FDA and ISO compliance
  • Support inspection readiness and regulatory audit responses
  • Ensure quality system documentation supports product lifecycle and change control activities Change Control; Quality Records
  • Manage engineering change control and quality record processes
  • Ensure traceability of revisions, approvals, and controlled documentation
  • Support design transfer and sustaining engineering changes from a quality systems perspective
  • QMS compliance status
  • CAPA cycle time and effectiveness
  • supplier quality performance
  • audit readiness and audit outcomes
  • documentation accuracy and traceability
  • quality system process compliance
  • VP Operations
  • Director of Technical Operations
  • Regulatory Affairs
  • Engineering

• Supply Chain And Procurement

  • Service Operations
  • Bachelor’s degree in Engineering, Life Sciences, Quality, Operations, or a related technical field
  • Equivalent relevant experience may be considered in lieu of degree
  • Advanced degree is a plus, but not typically required
  • 7+ years of progressive quality experience in a regulated manufacturing environment
  • 3+ years in medical device, diagnostics, or other highly regulated industry strongly preferred
  • Prior experience owning or administering a Quality Management System (QMS)
  • Demonstrated experience with CAPA, audits, supplier quality, and document control
  • Experience supporting FDA inspections and ISO 13485 certification audits
  • Prior startup or early-stage company experience strongly preferred
  • Experience with electromechanical medical devices or capital equipment
  • Familiarity with risk management / ISO 14971
  • Working knowledge of design controls
  • Experience partnering with Regulatory Affairs on submissions and inspections
  • Experience implementing or improving electronic QMS systems (eQMS)

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