SQE—某欧洲500强医疗行业公司

Job description

Ø        Implements Supplier Quality Assurance systems within the assigned region and plants, aligning to global policies and standard operating procedures (SOP).

Ø        Responsible for SOP deployment and training in the assigned plants.

Ø        Supports Category Managers, Manufacturing and R&D personnel in the supplier qualification and product validation activities.

Ø        Supported by the Category Managers, ensures the Supplier Quality Assurance

Ø        Agreements are distributed, discussed and signed.

Ø        Ensures the supplier performance monitoring and reports to management any deviation or major issue.

Ø        Supports suppliers in process validation, risk management and change management activities.

Ø        Follows suppliers’ recovery plans up, in case of poor performance, supervising the implementation of the remediation plans.

Ø        Performs second party audits as a lead auditor; defines and coordinates the audit team,if necessary.

Ø        Responsible to manage complaints to suppliers (non-conformity report), developing the culture of problem solving and promoting the use of suitable quality techniques and methodologies.

Ø        Ensures the implementation of corrective and preventive actions at suppliers, with the support of quality control manufacturing and R&D local functions.

 

Job requirements

Ø        Completed degree in mechanical engineering or electronic engineering a minimum professional experience of three years.

Ø        Advanced knowledge of applicable quality management standards (e.g. GMP EU and China, ISO 9001 and ISO 13485) and medical/medicinal devices regulations.

Ø        Advanced knowledge of supplier management and applicable tools and processes

Ø        Good and professional relationship to and communication with colleagues, superiors and to internal and external customers. Integrating attitude and team player.

Ø        High engagement on achieving the targets and on the objectives of the position, proactive and solution oriented approach towards problems

Ø        Good handling of moderation- and presentation technique e.g. written and oral

Ø        Ability to prioritize multiple projects and tasks

Ø        Experience in project management would be a plus

Ø        Advanced English language skill