Site Quality Manager (Healthcare)

Our client is a leading Healthcare & Life Sciences Diagnostics MNC. They are market leaders in the development production of a variety of innovative healthcare products globally. The company has a significant presence in Asia in terms of its reputable market position in developing high quality manufacturing and distribution capabilities, and takes pride in ensuring optimized end-to-end supply chain and quality management to achieve maximized customer satisfaction.

They are currently on an active look out for a suitable candidate as a Site Quality Manager (Healthcare), who is the critical point of contact in terms of ensuring Quality related actions supporting end to end Quality Management processes from New Product Development to QMS to Customer Quality Management, championing Quality Risk Management and related Supplier Quality Management activities.

Reporting to the Quality Director, and this position will be focussing on the below:

• Accountable for a smooth development and release of product engineering design implementation for existing and new product launches by means of ascertaining a feasible overall Quality Management Plan
• Ensure proper quality control and assurance process flows and required inspection procedures for the Singapore site(s)
• Active involvement in quality data analysis to derive continuous improvement opportunities to improve high volume quality management work flow, where required
• Contribute to strategic Risk Management processes by means of reviewing existing QMS workflow to ensure optimal Clean Room Manufacturing capability
• Identify product quality errors/ failure/ deviation and initiate or facilitate corrective and subsequent preventive actions by means of CAPA analysis etc

Candidate Profile
Singapore * Permanent

• Bachelor's Degree with at least 7 - 9 years of relevant experience in end-to-end Quality Engineering and Quality Assurance experience in a complex and high-volume Medical Device Manufacturing environment

• Proven track record in acquired solution oriented mind set to deal with complex Design Control Process and QMS work flow
• Excellent hands-on experience and knowledge in related Quality regulations such as FDA QS, ISO13485
• Excellent interpersonal communication skills to relay and/or drive process improvements across a global organisation to important stakeholders
• Good understanding of SAP (MM/PP modules) and equivalent ERP system is highly preferred

Singapore Employment Agency Licence No: 16S8069

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