- 1.Develop and implement quality management systems, policies, and procedures to ensure compliance with relevant regulatory requirements (BT, IS and UT ).
- 2.Establish and maintain effective relationships with regulatory authorities and notified bodies to facilitate product registrations, submissions, and audits.
- 3.Provide guidance and support to cross-functional teams during product development and manufacturing processes to ensure compliance with regulatory and quality requirements.
- 4.Review and approve product labeling, promotional materials, and documentation to ensure compliance with regulatory guidelines.
- 5.Stay up to date with relevant regulatory changes and industry trends, and provide proactive guidance to management on potential impact and necessary actions.
- 6.Coordinate and support regulatory inspections, customer audits, and external assessments.
- 7.Conduct risk assessments and participate in the development of risk management strategies.
- 8.Collaborate with cross-functional teams to investigate and resolve quality issues, non-conformities, and complaints in a timely manner. Train and educate employees on quality and regulatory requirements to promote a culture of quality awareness and continuous improvement.
- 9.Daily management of QA department and leadership development of subordinates.
- 1.Education / Degree: Bachelor degree or above, major in Engineering or Material Science is preferable.
- 2.Age Range: 35 to 50 years old.
- 3.Experience: Over 10 years QA management experience in foreign manufacturing company; Background in machining or automation industry is preferred; Rich social resources and external relationship is preferred.
- 4.Training/Certificate: Be trained / has knowledge in all major Industry and Piping System Standards (ISO 9001, 14001, OHSAS18001; DIN, GB, ANSI, JIS, etc.).
- 5.Specific knowledge: Familiar with machining or automation process; Sound knowledge of Lean Management.
- 6.Specific Skills: Profound knowledge and skills concerning design and operation of testing and inspection facilities.
- 7.Quality System: Detailed knowledge of ISO9001, 14001, OHSAS18001.
- 8.Language: Excellent Chinese in both oral and writing; Fluent English in both oral and writing.
- 9.Computer: Be familiar with all application of Microsoft Office tools; Be familiar with Quality Software is a plus.
- 10.Physical Attribute: Healthy.
- 11.Working Environment: Mainly indoor, including office and workshop.
- 12.Communication competency: Be able to understand others and affect, inspire, motivate staffs; For any emergencies (internal or external), be good at communicating and coordinating among all related sides with strong people relation skills.
- 13.Managerial Competencies: Highly proactive; Good planning in short and medium term, and be able to stick to the implementation; Strong learning willingness and ability, be able to accept different opinions and always seek improving to gain higher performance; Good analytical ability while facing complicated circumstances and problems, and be able to solve them under the right priority; Confident, and with decision making ability.
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