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Senior Medical Device Process Specialist
2 months ago
At Link Compliance, we are seeking a highly skilled and experienced Senior Medical Device Process Specialist to join our team.
About Us:
We are a renowned healthcare group specializing in innovative minimal invasive solutions. Our products and technology are widely used in diagnosing and treating various diseases across multiple medical fields.
Key Responsibilities:
- Lead the trial production, process validation, and mass production introduction during the transfer of domestic production lines.
- Optimize processes and manage production transfers based on product characteristics, developing comprehensive process documentation, including SOPs, drawings, and process flowcharts.
- Address technical, process, equipment, and tooling issues during production, analyze and improve significant production problems, and implement corrective actions.
- Assist with the procurement, transfer, and acceptance of production equipment and tooling, ensuring seamless integration into our manufacturing processes.
- Regularly generate detailed process reports and provide timely updates to the head office, facilitating informed decision-making.
- Perform additional tasks as assigned by superiors, supporting the growth and success of our organization.
Requirements:
- Excellent written and spoken communication skills in both Chinese and English, enabling effective collaboration with cross-functional teams.
- A full-time diploma or above in Mechanical Engineering, Automation, Materials Engineering, Electronic Engineering, Precision Machinery, or related fields, along with proficiency in office software.
- A minimum of 2 years of work experience, preferably in the medical device industry, demonstrating expertise in process development and optimization.
- Willingness to travel to China for short-term assignments, including work reports and training, showcasing adaptability and a strong work ethic.
Compensation: The estimated salary for this position is $80,000 - $110,000 per annum, commensurate with experience and qualifications.
