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Open nowFirst seen 5 days ago

Team Manager of Quality Assurance

DHD Consulting496 open roles

Where
Monroe Township, Georgia, United States
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Your applicationOpen nowTeam Manager of Quality AssuranceDHD Consulting · Monroe Township, Georgia, United States

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

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 and 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 57 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

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