Ensure the Company’s quality system is effectively implemented and supported in the Malaysia facility.
Implement and maintain effective statistical process controls and other statistical techniques to ensure manufacturing output is in control and monitored.
Responsible for the coordination of Incoming, In-Process, and/or Finished Goods Acceptance Testing;
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Plan, conduct, and document QMS internal audits in accordance with established audit schedules and company procedures.
Evaluate compliance with applicable regulations, standards, and quality system requirements, including ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other relevant global regulatory requirements.
Evaluate the effectiveness of quality system processes and ensure they are adequately documented, implemented, and maintained.
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Ensure the Company’s quality system is effectively implemented and supported in the Malaysia facility.
Implement and maintain effective statistical process controls and other statistical techniques to ensure manufacturing output is in control and monitored.
Responsible for the coordination of Incoming, In-Process, and/or Finished Goods Acceptance Testing;
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The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described
Conduct thorough inspections of incoming materials and components to ensure they meet established quality standards, specifications, and regulatory requirements.
Maintain accurate records of inspection results, test data, and any deviations from quality standards. Collect & maintain COC and all docs related to incoming material. Document non-conforming materials and initiate appropriate corrective actions.
Collaborate with supplier quality team to address quality issues, improve incoming material quality, and establish effective communication channels for resolving quality-related concerns.
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