Fency Chen

Fency Chen Email and Phone Number

Quality @
Fency Chen's Location
Valley View, South Australia, Australia, Australia
About Fency Chen

• 20 years foreign companies working experience: 4 years Engineering working experience in Electronic Industry, 12 years Quality Management working experience in Automotive Industry, 4 years R&D Quality Management working experience in Medical Device Industry working experience. • Be familiar with Quality System both in Medical Device Industry and Automotive Industry, such as ISO13485, GMP and IATF16949 requirements, CSR… • Good communication and influencing leadership experience in Fortune 500 companies.• Experienced in managing a small business in Australia.

Fency Chen's Current Company Details
Janssen-Cilag Pty Ltd

Janssen-Cilag Pty Ltd

Quality
Fency Chen Work Experience Details
  • Janssen-Cilag Pty Ltd
    Commercial Quality Professional
    Janssen-Cilag Pty Ltd Mar 2023 - Present
    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.
  • Johnson & Johnson Medical Pty Ltd
    Quality Assurance
    Johnson & Johnson Medical Pty Ltd Dec 2021 - Mar 2023
    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.
  • Johnson & Johnson Medical
    Senior R&D Quality Engineering Manager
    Johnson & Johnson Medical Jul 2013 - May 2017
    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.
  • Bosch Automotive Products (Suzhou) Co., Ltd.
    Senior Quality Manager
    Bosch Automotive Products (Suzhou) Co., Ltd. Mar 2005 - Jun 2013
    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.

Fency Chen Skills

Ppap Quality Control Continuous Improvement Testing Process Improvement Quality System Cross Functional Team Leadership Product Development

Fency Chen Education Details

Frequently Asked Questions about Fency Chen

What company does Fency Chen work for?

Fency Chen works for Janssen-Cilag Pty Ltd

What is Fency Chen's role at the current company?

Fency Chen's current role is Quality.

What schools did Fency Chen attend?

Fency Chen attended University Of North Alabama, Shanghai University.

What skills is Fency Chen known for?

Fency Chen has skills like Ppap, Quality Control, Continuous Improvement, Testing, Process Improvement, Quality System, Cross Functional Team Leadership, Product Development.

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