The Offer
- Fantastic work culture
- A role that offers a breadth of learning opportunities
- Work alongside & learn from best in class talent
The Job
Your responsibilities will include :
- Acting as the Quality Leader, he / she will report directly to Singapore HQ for all Quality matters for Irvine Service Centre (ISC).
- Ensures ISC complies with all relevant local, state and federal regulations and obtains necessary certifications and approvals from regulatory bodies including FDA and ISO
- Develop and implement a robust QMS for ISC by working closely with Singapore HQ
- Prepares plan for GxP software implementation together with Service Operations team for proposal to top management.
- Strategize and develop a sustainable model for execution of quality event reporting for internal and external stakeholders.
- Works closely with Service Operations, Customer Service team to co-develop an efficient process flow for servicing medical equipment returns.
- Handles customer complaints, investigations
- Lead and drive all validation activities during the setup phase of the ISC
- Establish, develop and document Quality SOPs and WI for all service center operations.
- Leads and prepare Irvine team for internal and external audits
- Oversees daily tasks related to Quality operations
- Perform other ad-hoc duties as assigned by immediate supervisor.
The Profile
- Degree in Engineer or related field
- Passion for detail with strong drive to complete tasks timely and efficiently
- Strong working knowledge of ISO 13485 and FDA QSR.
- Strong working knowledge of Verification and Validation concepts
- Qualified Lead Internal Auditor experience will be a strong advantage
- Demonstrate strong understanding of QMS setting up and maintenance processes.
- Candidates with good qualifications and experience may be considered for a more senior role
The Employer
Our client is looking for an excellent team player with professional work ethics to join us for a new exciting role. Successful candidates will be assigned to work on the latest surgical and imaging technologies!
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