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Cochlear Ltd. - Quality Systems Specialist (Chengdu)

Apply nowJob no: Protected content
Work type: Permanent
Location: Chengdu
Categories: Manufacturing & Logistics, Asia Pacific, Individual Contributor
Accountability 1: Quality Management System Standardisation and Support (40%)

· Protected content the Chengdu Quality Management System and collaborate with corporate stakeholders at CLTD ensure alignment with business requirements

· Protected content change control to the QMS, and incorporate global process changes as necessary with appropriate gap analysis to local requirements

· Protected content local and site-specific procedures and WIs are created/maintained to meet local regulation requirements, when global processes are not fit for purpose

· Protected content new requirements and regulation changes into the Chengdu QMS

· Protected content , initiate and implement improvements to QMS processes

· Protected content changes to regulations, monitor industry trends, and maintain knowledge to ensure Chengdu site remains compliant to requirements

· Protected content the Chengdu document control program

Accountability 2: Support Audit, Training and CAPA Activities (40%)

· Protected content the Chengdu site quality system self-assessment and internal audit programs

· Protected content regular Internal and Supplier audits

· Protected content with stakeholder to support external audits

· Protected content the Chengdu site quality training program

· Protected content regular quality compliance and process awareness training to stakeholders

· Protected content with CLTD to ensure CAPA excellence, and deliver timely and effective corrective and preventive actions

Accountability 3: General Quality Support (20%)

· Protected content with stakeholders to prepare the quality management review materials and ensure the actions are on track

· Protected content Quality SME review of documents for proposed changes (e.g. Insight, Windchill).

· Protected content periodic reports and metrics and ensure timely delivery of scheduled activities

· Protected content the site to build and promote a quality culture through regular activities such as quality events

Team Role (Individual contributor):

Follow relevant quality procedures in order to deliver quality products and services and identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.g. audit) when appropriately trained to undertake these responsibilities.
Contribute ideas on systems and process methods to improve deliverables.
Work safely, complying with all safety procedures, rules and instructions; and reporting workplace hazards, incidents or injuries to manager

Minimum:

Bachelor’s Degree in Science or Engineering or equivalent
Fluent in English language, both written and oral
Minimum Protected content experience with Quality System management and exposure to ISO, PMDA, FDA and other regulatory agency inspections in the medical device or pharmaceutical industry
Experience with establishing and maintaining a Quality Management System for Medical Device or Pharmaceutical manufacturing companies
Methodical approach to problem solving

Ideal:

ISO Protected content auditor or lead auditor certification
Medical device registration experience
Knowledge or experience with MRP/ERP systems (e.g. Oracle)
Experience with electronic systems for document management, training, and/or CAPA
Knowledge of Manufacturing processes
Advertised: 28 May Protected content Standard Time
Applications close: 31 Jul Protected content Standard Time

If you are excellent,please apply here: Protected content

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