Fency Chen Email & Phone Number

Sydney, New South Wales, Australia

• Ensure that Suppliers management is managed in line with J&J requirements incl.leading suppliers’ assessments and monitoring, creation, management andnegotiation of Quality agreements with suppliers and monitoring of suppliers’CAPA.• Ensure that robust processes are in place and maintained to take product relateddecisions with required documentation, coordinate with Supply Chain and otherstakeholders for any projected issues that may impact product availability to thepatients.• Ensure that all quality issues for products and associated systems are suitably,scientifically and logically handled, documented, investigated for root cause andassessed for its impact on product quality and safety, incl. product dispositiondecisions taken and documented.• Ensure appropriate corrective actions and preventive actions (CAPA) are taken tomitigate the effect of a quality issue as well as to prevent recurrence in the future.• Escalate product quality, safety and compliance issues and support the conduct ofrecalls and other field actions in a timely manner.

Australia

• Initiate and manage recalls and stop shipments for Australia and New Zealand.• Manage life cycle of recalls and stop shipments – customer follow up with internal (including Franchises) and external customers to action, manage and close recalls and stop shipments.• Manage recalls and stop shipments - affected stock including SAP hold status, disposition, and reconciliation• Reports as required by TGA and Medsafe, Internal Metrics and KPIs.• Input and update data in recall systems REACT and Recall health (Recall net).• Conduct internal periodic audit and support external ISO13485 audit.

Suzhou, Jiangsu, China

- Manage the development and continuous improvement of Quality Systems for China R&D in alignment with regional / franchise objectives and sector/corporate quality standards.- Ensure site compliance with the Suzhou and BU/Franchise Quality Management Systems, government regulations & international standards requirements.- Manage Team of Quality Engineers supporting product development efforts in the China R&D Facility and New Business Development assessments in AP.

Position: Senior Quality Manager• Manage incoming inspection process to guarantee quality of components• Coordinate the activities with production and TEF for quality issues to implement correctives actions and guarantee that specifications and quality levels are met.• Implement Quality plan and activities to satisfy Customer requirements. Manage customer concern / complaint (reaction plan and communication). • Responsible for Quality Laboratory (Routine test and quality analysis).• Ensure TS 16949 system set up / maintenance and process improvement.• Develop Quality team to meet further quality requirement.• Responsible for safety in QMM team and QMM area.Position: Supply Quality Manager- Lead the PUQ group to provide quality support to purchasing for supplier selection and development.- Monitor supplier performance and identify supplier development needs.- Manage and support supplier development activity. - Plan, coordinate and monitor execution of supplier audits.- Leading in resolution & prevention of supplier related quality concerns.- Support compliance to ISO/TS16949 requirements.Position: Customer & Process Quality Manager- Handle all CB (Chassis Brake) customer quality issues of 0km and field claims. - Product analysis and containment activity at customer location. - Launch support for new products.- Monthly update the PPM of claims to internal for locally produced parts and update to lead pants for imported parts. - Timely and effective 8D response to customers. Keep information updated via telecom with customers and lead parts for claims.- Develop contacts with customers, lead plants and keep the good relationship.- Handle process quality.- Set up year quality target and conduct performance review.

Emba

Bachelor'S Degree