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Quality System Analyst (Carlsbad)

Quality System Analyst (Carlsbad)

Bolt MedicalCarlsbad, CA, United States
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DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS : DO NOT CONTACT.

SUMMARY OF THE JOB :

We are seeking a detail-oriented and analytical Quality Systems Analyst to support and enhance our quality management systems (QMS) in compliance with FDA regulations, ISO standards, and other global medical device requirements. This role is critical in maintaining product integrity, regulatory compliance, and continuous improvement across our operations.

Responsibilities :

  • Maintain and monitor the QMS to ensure compliance with ISO 13485, FDA QSR, EU MDR, MDSAP, and other relevant regulations.
  • Support internal and external audits, including preparation, facilitation, response, and follow-up on corrective actions.
  • Review and maintain quality documentation, including SOPs, work instructions, forms, and records.
  • Lead or support CAPA (Corrective and Preventive Action) investigations, root cause analysis, and effectiveness verification.
  • Manage document control activities, ensuring timely approval, release, and archival of controlled documents.
  • Monitor and analyze quality metrics, trends, and KPIs to drive process improvement.
  • Support training programs to ensure employee awareness and compliance with QMS requirements.
  • Collaborate cross-functionally with engineering, manufacturing, regulatory, and supply chain teams to ensure quality standards are met.
  • Participate in risk management activities in alignment with ISO 14971 requirements.
  • Contribute to continuous improvement initiatives related to QMS processes, efficiency, and effectiveness.

Qualification :

  • Bachelors degree in Life Sciences, Engineering, Quality, or related field (or equivalent experience).
  • 25 years of experience in Quality Systems within the medical device, pharmaceutical, or related regulated industry.
  • Strong knowledge of ISO 13485, FDA 21 CFR 820, EU MDR, and other applicable regulations / standards.
  • Experience with CAPA management, internal auditing, and document control processes.
  • Excellent analytical, organizational, and problem-solving skills.
  • Strong written and verbal communication skills; ability to work cross-functionally.
  • Proficiency with electronic QMS systems (eQMS) and Microsoft Office Suite.
  • ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) preferred, but not required .
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