Lee See

Senior Quality Manager and Site QMR

Haemonetics

Jun 2022 - Current (4 years 3 months)

Site Quality Leader in lead the site quality management system, regulatory and certification audit, quality engineering, quality operation, complaints handling, risk management, CAPA and NC Management, process validation, test method validation, new product transfer qualification, sterilization control, product LAL, bioburden test, environment control such as particle count and microbial count • Lead the quality team to ensure plant compliance with regulatory requirement, such as GDPMD, 21CFR 820, EUMDR etc • Responsible to plant quality performance, facilitating cross-functional interaction and communication between Quality, Regulatory Affairs, Sales & Marketing, Field Service, R&D, Manufacturing, Operations, for subsequent product quality

Senior Quality Operation Manager

Teleflex Incorporated

Oct 2019 - Jun 2022 (2 years 9 months)

-Head of department in quality operation -Responsible in leading operation plants to comply to ISO 13485 and 21 CFR 820 Quality System Regulation, local and global standard procedure, product release according to product specification, operation continue to produce high quality and compliant medical devices. -Trains, develops, and provides technical guidance to quality engineers and cross functional team, for process improvement, standardization initiatives, and continuous improvement activities. -Lead and support site’s CAPA –detail technical review and approval of the CAPAs to ensure compliance to standard and effectiveness. - Drive quality culture- Define, promote and strengthen unified quality culture and behaviour across employees -

Quality Assurance Manager

B Braun Group

Jan 2015 - Sep 2019 (4 years 9 months)

• Heading Medical Quality Compliance Department by overseeing 14 employees • Certified as International Register of Certificated Auditors (IRCA) British for ISO13485:2016. Successfully lead the company to obtain TUV ISO13485:2016 Certification. • Overview the operation compliance to USFDA QSR/GMP(21 CFR Part 820, 21 CFR Part11), ISO 13485:2016, ISO14971, J-QMS. Ensure effective implementation of Quality Management Systems and GMP Compliance requirements across divisions. • Manage all internal and external audit at BMI, Penang including regulatory audit, customer, and external certification body (e.g. FDA, Ukrainian Medical Certification Centre, Korean Authority Inspection) Key achievement including leading Medical Plant through 2 times FDA

Senior Quality Assurance Engineer

Agilent Technologies

Jan 2012 - Dec 2014 (3 years)

• Setup new manufacturing site for Quality Assurance function which include but not limited to: -Quality Assurance (Incoming Quality; Manufacturing Operations Quality) -CAPA - Corrective Action Board; Metrics -Materials Control – Receiving Inspection -Supplier Quality Management -Management Responsibility that includes Executive Management Reviews -Auditing Product and Process Control - In-Process Inspection -Statistical Techniques; Product Release; -Provide support and guidance in preparation of responses to Internal, Division, and external audit • Successfully setting up the quality system in full compliance with ISO9001 requirement. Obtain third party certification approval for ISO 9

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Quality Engineer

Venture Electronis Service Sdn Bhd

Jul 2008 - Jan 2012 (3 years 7 months)

• Oversee Venture’s customer product quality performance. • In charge of new product transfer and line setup in Venture Operation. Oversee the line qualification process. Ensure readiness of assembly process, process control plan, calibrated equipment and tooling, testing procedure, qualification of test station been qualified, engineering training effectiveness and etc. • Review new product build qualification result. Work together with test engineer to investigate and drive improvements for those FA fail units which causing low yield. • Setup SPC chart for new product line functional test. • Establish FMEA for new products. • Manage customer complaints, help to get a detailed problem description and assign subject matter experts to perfor

Customer Quality Engineer

Sumitomo Electric Industries Ltd

Jun 2005 - Jun 2008 (3 years 1 month)

• Appointed to oversee Asia Pacific Customer experience and subcontractors QMS site audit and quality performance. • Manage Asia Pacific Customer Complaints from receipt until reply to the customer with 8D reports. • As single point of contact person to Asia Pacific Customer to oversee the new product requirement & new technical specification. • Oversee new product qualification processes. • Regular visit Asia Pacific Customers to update overall product quality performance, continue improvement projects. • Visit new potential Asia Pacific Customers to promote manufacturing service in order to get a new business. • Manage customer audit and in charge of audit preparation. • Notify customer for any process changes and coordinate to provide su

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Medical Laboratory Scientist

LOH GUAN LYE Specialist Hospital

Apr 2002 - May 2005 (3 years 2 months)

• Perform chemical, hematological, immunologic, histopathological, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid (CSF), peritoneal fluid, as well as other specimens. • Advise health care specialists in the diagnosis and treatment of patients. • Ensure the safety and reliability of tests and equipment used in healthcare. • Establish Standard Operation Procedure (SOP) and developing analytical methods for equipment used.

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