Job Title
Quality Engineering Manager
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About the Role
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This role oversees critical projects for new production introduction, providing leadership to a team of quality engineers.
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Key Responsibilities
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* Ensure alignment with international quality standards, such as ISO 9000 and ISO 13485, crucial in the medical devices/pharmaceutical industry.
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* Guarantee regulatory compliance by ensuring all activities meet required standards.
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* Lead the Quality Engineering Team through daily management, performance reviews, and delegation.
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* Support programs like Six Sigma to enhance processes and product quality.
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* Oversee systems related to production support, including non-conformance, incident reporting, and customer complaint analysis.
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* Liaise with key external customers to ensure quality standards meet their expectations.
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* Ensure Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards.
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* Verify Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities.
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* Prepare and maintain documentation to meet regulatory requirements.
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