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.
• 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.

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.

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.

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.

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.

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