Stanley Ooi Email & Phone Number

Kedah, Malaysia

• Regional role responsible for multiple sites in Malaysia and China, for ETO, Gamma and X-Ray processing modalities. • Supported in facility expansion project (included setting up the first X-Ray processing capability in APAC and ETO Chambers expansion), driving the QMS readiness which resulted to a successful ISO13485 scope extension audit with zero nonconformity.• Extended the X-Ray processing capability set up experiences and support to sister facility in Thailand.• Host FDA inspection, notified body and various Customer audits for the site, and extended QMS support to lead backroom office during FDA inspection at sister facility. • Establishes quality objectives and ensures the sites quality metrics are met.• Responsible for ensuring the company Quality Management Systems is in compliance with applicable standards and regulatory requirements.• Coaches, mentors, and develops staff. Leads a team of Executives, Supervisor, QC Leaders and Inspectors.• Oversees and approves validations activities such as IQ, OQ and PQ. • Participates in Global Procedures / Work Instructions review and ensures the requirements are implemented at site level accordingly.• Ensures Nonconformances, CAPA and Customer Complaints are managed effectively and closed in timely manner. • Conducts Quality Management Review meetings on quarterly basis. • Ensures internal audit is carried out in timely manner and corrective actions are closed effectively.• Manages Supplier Management program and calibration process.• Reviews and approves change controls. • Authority to stop processing activities if procedures are not being adhered to. • Oversees training process. • Reviews Customer feedbacks/surveys and works with cross functional team for improvements when necessary. • Performs gap analysis when there is any change in the ISO requirements. • Lean Champion to support various lean activities at site level.

Kulim, Kedah

Joined Abbott Medical Optics as part of a pioneering team to lead and set up Supplier Quality Management (SQM) function in the company. Established the regulatory-compliant SOPs/processes related to SQM with minimal supervisions and guidances. Performed and supported supplier quality evaluations and/or audits, development of quality agreements, supplier performance metrics and other supplier quality related activities, which massive suppliers were assessed during the start up. Apart from that, I was also tasked to coordinate the BOM/Part Number set up in SAP, across various functional teams in Malaysia, US and Netherlands. Being a Subject Matter Expert for supplier management, I also presented for various major audits, example FDA, TUV (ISO13485), Dekra, Corporate / Divisional audits and so on, at the same time being a key support at front room during audits. Served as back-up/acting to Global Senior SQ Manager to participates in site quality and/or management meetings to ensure communication and alignment of quality initiatives. Represented the site to participate in Global SQ Integration & Harmonization Project (AMO to JJV) to have a standardized supplier management process across JJV sites. The activities included integrating site procedures, Approved Supplier List, quality agreements and so on to global process / procedures.Also represents Johnson & Johnson Vision (Division) to participate and engage in various global activities, which included APAC SQ Community Meeting, and Corporate SQ SOPs Team in delivering a standardized and compliance process between Corporate and Division. Leads activities associated with supplier process improvement, such as Proactive Supplier Engagements. This includes working with suppliers to identify sources of variation within their processes; implementing process controls to improve process capability; and driving implementation of best practices. Being selected and completed the Company Leadership Program.

Penang, Malaysia

Part of global SQ team to ensure operational, functional and compliance excellence. Maintained and managed Approved Suppliers List for Malaysia site. Conducted external supplier audits as assigned to ensure QMS compliance. Recommended and evaluated new suppliers to grow the business and improve operational efficiency and quality levels. Worked closely with cross-functional teams across departments including senior managements to ensure suppliers are delivering quality products. Provided support and assistance during internal and external audits. Managed to negotiate with suppliers and close several quality agreements which had opened for several years

Bayan Lepas, Penang

Joined Supplier Quality team to expand experiences and knowledges of various areas. Took part in new supplier selection and qualification process, including the evaluation and approval of new suppliers. Drove material quality improvement initiatives. Trained and certified as Internal Lead Auditor, at the same time perform periodic audits of supplier quality system for the purpose of assuring continued supplier conformances to the quality system requirements.

Bayan Lepas, Penang

Joined St Jude Medical as part of a pioneering team and tasked to lead and set up a Metrology Laboratory in the company. I led the Metrology department to pass the various major audits, such as FDA, TGA, CCC, TUV, ANVISA and PMDA without any non-conformances. By 2012, I managed to save about $130k per annum by bringing in about 80% of the calibration jobs to be done in-house. I also expanded lab capabilities to provide site calibration support to Software Development team in India. Apart from Metrology function, I was also responsible to lead in ESD verifications during ESD audit. I was also trained and qualified as Internal Lead Auditor for both ISO13485 & ISO14001. Besides, I was being selected and completed the Company Leadership Program.

Bayan Lepas, Penang

Developed new device verification and characterization strategies, together with their corresponding plans and schedules. This involved resource planning, negotiation, and the designing of test and measurement methods for NPI devices

Bayan Lepas, Penang

Worked closely with Manufacturing, Marketing and Product Engineering teams to ensure successful delivery of quality products to customers