Job Description

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!

Job Tags

Similar Jobs