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We are seeking a technically skilled Product Support Engineer to ensure continuous compliance and optimization of our continence care product . You will work as the single-point-of-contact for product performance, bridging HQ and manufacturing sites in Hungary with Zhuhai site through: Design control maintenance & regulatory compliance; Risk management file updates; Technical documentation reviews; Cross-functional coordination for product technical related issue.
Job Responsibility:
Support product transfer within pilot/ramp-up or mass-production sites by completing relevant PS activities
Perform design verification and report, provide internal training of product, material and end-user knowledge
Cooperate with relevant RA and QA to ensure design control and product meet the quality and regulation standard
Apply risk management and support on maintain risk management files
Give input to PMS (post-market surveillance) reports and participate in Product Review meetings if relevant
Create and maintain specifications, product description and composition (PDC) documents
Handle relevant activities in Change Control and update Manufacturing Flow Chart
Approve stability, transportation studies/reports and product drawings
Contribute to DHF/DMR and project documentation with essential PS knowledge
Analyse product performance (against intended use) and conduct comparison tests against competitors’ products
Requirements:
Bachelor’s degree in relevant technical background, e.g. Engineering, Pharmaceutical or Life Science (organic Chemistry or applied chemistry is preferred)
At least 3 years of technical support experience or equivalent experience in relevant R&D, Quality or RA function
Good knowledge of legislation, system, and procedures applicable to the medical device industry
Basic data processing, statistical and analytical skills
Be familiar with MS Office / Lotus Notes or equivalent / Veeva or other e-documentation system
Experience with the medical device/life science industry in an international company is preferred
Be proficient in English, both verbal and written
What we offer:
Good place to work
Attractive career path and growing opportunities
A modern company who values people’s engagement with a work-life balance culture