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- Responsible for all QC activities to ensure high quality products are delivered.
- Maintain all QC Department Quality Management System in ensuring compliance with regulatory requirements and quality standards such as ISO13485 and cGMP.
- Responsible for all QC activities, develop and implement quality control of supplier, incoming, in-process and outgoing to ensure high quality products are delivered.
- Lead and supervise a team of QC staff to achieve defined goals and initiatives.
- Manage all Quality issues related to the process and product. Provide quality engineering support to ensure conformance to customer specification and requirement.
- Work closely with QA, inter-department and suppliers in solving quality issues and meeting quality requirements.
- Verify on customer complaints/return, perform failure analysis and identify effective corrective/preventive actions.
- Manage Customer Complaints, Corrective Action, Preventive Action and Continuous Improvement programs for all processes.
- Plan & Conduct Audits on Internal/Supplier Systems.
- Generate and analyse weekly, monthly performance reports for customer, in-house and suppliers.
- Participate in activities for new product introduction and product transfer to insure proper production start-up.
- Review products for DFX practices.
- Bachelor’s degree or equivalent in a related field.
- 8+ years quality control or manufacturing experience.
- 5 to 8 years of supervisory experience.
- Strong communication, public-speaking, decision-making, MS Office, and negotiation skills.
- Strong customer orientation and focus.
- Excellent technical and analytical skills required.
- Familiarity with SAP or similar ERP systems a plus.
- Thorough understanding of ISO 13485, FDA regulations and GMP requirements.
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