Regional Quality Manager (Medical Devices)
Our client is a global MNC in the medical device sector. They are market leaders in the development production of a variety of innovative life sciences diagnostics 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 lookout for a suitable candidate as a Regional Quality Manager (Medical Devices), who is the critical point of contact in terms of ensuring optimal Design Quality related actions in support of New Product Development (NPD) and supporting systems, championing Quality Risk Management and R&D Design Control as well as the related process flow.
Reporting to the Global Quality Director, this position will be focussing on the below:
- Lead and mentor a team of Quality professionals, and to strategically support the ramp-up of manufacturing operations and product design procedures
- Accountable for smooth development and release of engineering design implementation for existing and new product launches by means of ascertaining a feasible overall Quality Management Plan
- Spearhead proper quality assurance process flows and required control and inspection procedures, including that of reliability testing and supporting process and/or product validation
- Lead continuous improvement initiatives and periodic review, disposition, and corrective action activities associated with discrepant raw materials or finished goods
- Contribute to strategic Risk Management processes and the necessary system-level procedural requirements, and also to optimally support Quality System of the development site(s) and CAPA processes etc
Singapore * Permanent
- Bachelor's Degree with at least 6 - 8 years of relevant experience in end-to-end Quality Engineering experience in a GMP environment
- Proven track record in an acquired solution-oriented mindset to deal with complex Design Control Process and QMS workflow
- Excellent hands-on experience and knowledge in related Quality regulations such as FDA QS, ISO14971
- 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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