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12 มิถุนายน 2563
รหัสงาน: CH-15855
Head of Quality for Medical Devices & Pharmaceuticals
Responsibilities:
  • Maintaining professional competence in a wide range of technical, scientific and regulatory fields while promoting excellent working relationships with other departments including the Management Team.  The incumbent is expected to operate with a heavy reliance on personal experience, knowledge and skills while always following and promoting the company Core Values. 
  • Being hands-on technical expertise in resolving issues and identifying risks. This may include recommendations as to appropriate actions and evaluations of resources required.
  • Handling the development of staff and overall organization is a vital aspect of this position. Methodologies such as career development plans/actions, empowerment, diversity practices, teamwork, coaching and training must be utilized.
  • Maintaining and developing the QMS program to be compliance with ISO9001:2015 requirements including full support to internal auditors to be successful while conducting the internal audit.
  • Leading the team during the qualification and validation of products, process and material to ensure that they are in good condition and stable trend before releasing to production.
  • Ensuring that tests and procedures are properly understood, carried out and evaluated and assessing product specifications of the company and compare with customer requirements.
  • Coordinating with the production department and related sections in the resolution of quality problems and in analyzing these problems for continuous improvement.
  • Flow down global information to staff and liaising with customers and other external support and ensuring the execution of corrective action in compliance with customers and company specifications.
  • Handling the product & process quality with the strategy of continuous improvement for the day-to-day responsibilities of QC Inspection, labs to ensure support of the Operations.
  • Supporting the implementation of Operational Excellence, Lean Six Sigma, 5S and all related activities.
  • Ensuring that within the Quality Operations area the QMS is followed and Standard Work is implemented and maintained and follows all Quality System requirements.
  • Setting the performance objectives for the team to be a part of the progress team in each workshop and fully support to continuous improvement program which is can improve customer satisfaction and overall performance of the organization. 
  • Being responsible for the regulatory and good manufacturing practice compliance as outlined in the Quality Manual, Policies and Procedures.
  • Managing the total supplier quality process including supplier approval and inspection of incoming raw materials.
  • Being responsible for monitoring and evaluating direct reports for compliance with workplace safety and environment policy.
  • Managing related audits and ensure compliance with government institutions.
Qualifications:
  • Bachelor’s Degree or higher in Chemical, Physical sciences, Engineering, or related field
  • At least 15 years' experience in quality management jobs, especially works relating to the quality system and 10 years in supervisory level.
  • TOEIC score above 700.
  • A comprehensive understanding of quality system requirements and processes, within manufacturing operations, is required.
  • Knowledge and experience of GMP, FDA, ISO13485 standard; capable of managing a Cluster Microbiologist team and Quality Service team.
  • Good interpersonal and communication skills.
  • Very good English communication skills (reading, writing, and speaking).
  • Must be comfortable in a customer-facing role, understanding the need for being diplomatic but assertive.
  • Willing and capable to work with cross-functional teams.
  • Good leadership skill.
Our client offers a basic salary, allowance, provident fund, group insurance, a fixed and variable bonus, and a five-day working week.
 
Reference Code: HQ1101206

รายละเอียดงาน:

PRTR Recruitment and Outsourcing (Eastern Seaboard) Co., Ltd.
https://www.prtr.com/
Our client is a leading global manufacturer of automotive parts.
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