I have been in Supplier Quality Management over 20 years of experience in the areas of Hard Disk Manufacturing, Equipment Contract Manufacturing, Pharmaceutical and Medical Devices Manufacturing industries. My key area of responsibilities involves in
As a Senior Supplier Quality Engineer:
- Primary Subject Matter Expertise of Supplier Quality Management area supporting regulatory audits (Eg: Dekra, FDA, Japan and China audit) and internal audit, follow up on the CAPAs to ensure closure on time.
- Lead and execute supplier assessment including of selection and evaluation of potential suppliers, audits, qualification of new supplier for material and service activities.
- Provide support to investigation teams in determining root causes on material quality issues and initiate/ensure supplier corrective and preventive action plans are developed and executed.
- Bridge to ensure material issues detected by customers are reviewed against internal production material performance, and ensure internal key stakeholders jointly take immediate actions (including Purge, Stop Shipment/Production) to contain the material problem and to address to suppliers.
- Interface with Suppliers, Engineering/ Manufacturing/ Quality Assurance/ Procurement departments to identify and drive for quality improvements, specifically on incoming rejects.
- Manage and lead Supplier Management process to support NPI projects such as sourcing in supplier selection and evaluation of potential suppliers, supplier approval activities (inclusive of part & service qualification), maintaining and monitors supplier performance over time and takes appropriate action to ensure ongoing compliance.
- Establish Supplier Quality agreements with suppliers and interplant companies to ensure the required quality system elements a supplier must maintain.
- Liaise with Corporate and interplant sites for supplier audit management. Schedule and lead Supplier audits for high-risk suppliers to assess their quality systems, evaluate supplier performance, technical capabilities and assure they are compliance to regulations applicable to production of medical devices.
- Lead on-site supplier qualification and surveillance audit, follow up on audit findings to ensure all suppliers closed the corrective action on time.
- Prepare Supplier Quality metric for management review program.
- Track and review supplier performance, qualify or disqualify suppliers according to procedure.
- Train and certify new Engineers to be lead auditor.
As a Receiving Incoming Supervisor:
- Manage and lead a team of 4 Receiving Incoming Inspectors, provide training, mentoring, evaluating their performance and disciplinary actions.
- Develop inspection plans and update receiving procedure.
- Collaborate with key stakeholders (Supply Chain/Quality Engineering/Manufacturing Engineering/R&D/Supplier) to ensure the required part specifications and receiving process sheets are implemented for Incoming quality inspection.
- Cross-functionally coordinates with the Procurement team assigned to support supplied products and materials (inclusive of First Article Inspection activities).
I have knowledge and working application of 21 CFR Part 820 and MDSAP requirements, 6S, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Documentation Practice (GDP) and application of Quality Tools like Root Cause Analysis, DMAIC, 8D methodologies, FMEA, SPC, Gauge R&R etc. I am supporting new product transfer project to onboard new suppliers/receiving materials into the plant to ensure the transferring process is smooth and successful.
On several occasions, I have been recognized and awarded by Corporate Supplier Quality Department head and local multiple department heads for the quality, strong leadership, productivity and efficiency of the work I contribute during my career. You may refer to my attached resume for your further reference. I look forward to having the opportunity to discuss my application further.
I deeply thank you for your attention in considering me for this position.
Sincerely,
Seah Siew Inn.
