Quality Assurance Manager

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This range is provided by Clin Lab Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$80,000.00/yr - $/yr

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Position Summary

Experienced Quality Assurance professional with 5-7 years in the medical device industry, focused on audit response, CAPA, validation, and document control within ISO 13485-compliant environments.

Duties & Responsibilities

• Prepare and maintain the quality system in a state of audit readiness.
• Lead internal preparation and documentation support for regulatory, customer, and certification audits (e.g., ISO 13485/cGMP/MDSAP/IVDR/WHO PQ).
• Respond to auditor inquiries and ensure timely resolution of findings.
• Manage the full lifecycle of Corrective and Preventive Actions (CAPA), including root cause analysis, implementation of corrective actions, effectiveness checks, and documentation.
• Collaborate with cross-functional teams to ensure long-term compliance and quality improvements.
• Lead and coordinate equipment, process, and software validation activities.
• Ensure proper planning, protocol development, execution, deviation handling, and reporting are in compliance with regulatory requirements and internal procedures.
• Oversee creation, revision, approval, and archiving of controlled documents including SOPs, work instructions, forms, and quality records.
• Ensure alignment with document control policies and support training on new or revised procedures.
• Support the implementation and monitoring of QMS elements (ISO 13485).
• Lead quality initiatives and gap assessments, and drive continuous improvement through internal audits, KPI monitoring, and quality review meetings.

Qualifications

• Bachelor's degree in Biomedical Engineering, Biotechnology, or a related field in life sciences or engineering
• Minimum of 5–7 years experience in Quality Assurance within the medical device or pharmaceutical industry, including audit preparation, nonconformance handling, and quality system maintenance

Knowledge, Skills, and Abilities

• ISO 13485 Internal Auditor certification (preferred)
• RCC-MDR or equivalent regulatory training (preferred)
• English and Korean bilingual (preferred)
• In-depth understanding of ISO 13485 and QMS requirements
• Experience with CAPA systems, validation protocols (IQ/OQ/PQ), and document control procedures
• Strong attention to detail
• Problem-solving mindset
• Effective communication and documentation skills
• Ability to work in cross-functional teams

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance
• Industries Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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