Team Manager of Quality Assurance
On-siteMonroe Township, New Jersey, United States
Job Summary
Prepare and maintain the quality system in a state of audit readiness for regulatory, customer, and certification audits such as ISO 13485, cGMP, and MDSAP. Lead internal preparation and documentation support while responding to auditor inquiries and ensuring timely resolution of findings. Manage the full lifecycle of Corrective and Preventive Actions (CAPA), including root cause analysis, implementation, and effectiveness checks. Collaborate with cross-functional teams to ensure long-term compliance and quality improvements through continuous improvement initiatives, KPI monitoring, and quality review meetings. Oversee equipment, process, and software validation activities, including protocol development and deviation handling. Oversee creation, revision, approval, and archiving of controlled documents including SOPs and quality records. Support training on new or revised procedures and monitor QMS elements. Requires 5-7 years of experience in the medical device industry.
Required 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
Desired Qualifications
- 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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