Quality Assurance Manager (Healthcare)
|Job Title:||Quality Assurance Manager (Healthcare)|
|Contact Name:||Choo Hui Ting|
|Job Published:||April 20, 2021 10:52|
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 Quality Assurance Manager (Healthcare), who is the critical point of contact in terms of ensuring Quality related actions supporting end to end Quality Assurance processes from New Product Development QA testing, Incoming Batch Release and Outgoing Product Quality Management etc., championing Quality Risk Management and Compliance.
Reporting to the Senior Quality Manager, 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 ensuring proper review and validation protocols for product and process changes
- Active involvement in quality data analysis to derive continuous improvement opportunities and detailed failure investigations
Ensure proper Quality Assurance documentation for non-conforming materials and products
- Lead and be actively involved in internal and external Quality Audit to optimise compliance to quality and regulatory requirements
- Contribute to strategic Risk Management processes by means of reviewing existing QMS workflow to ensure optimal Clean Room Manufacturing capability
Singapore * Permanent
- Bachelor's Degree with at least 7 - 9 years of relevant experience in end-to-end 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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