Product Support Engineer

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.

Essential Duties / Responsibilities

1.Support product transfer within pilot/ramp-up or mass-production sites by completing relevant PS activities

2.Perform design verification and report, provide internal training of product, material and end-user knowledge

3.Cooperate with relevant RA and QA to ensure design control and product meet the quality and regulation standard

4.Apply risk management and support on maintain risk management files

5.Give input to PMS (post-market surveillance) reports and participate in Product Review meetings if relevant

6.Create and maintain specifications, product description and composition (PDC) documents

7.Handle relevant activities in Change Control and update Manufacturing Flow Chart

8.Approve stability, transportation studies/reports and product drawings

9.Contribute to DHF/DMR and project documentation with essential PS knowledge

10.Analyse product performance (against intended use) and conduct comparison tests against competitors’ products

Qualifications 

 1.Bachelor’s degree in relevant technical background, e.g. Engineering, Pharmaceutical or Life Science (organic Chemistry or applied chemistry is preferred)

2.At least 3 years of technical support experience or equivalent experience in relevant R&D, Quality or RA function

3.Good knowledge of legislation, system, and procedures applicable to the medical device industry

4.Basic data processing, statistical and analytical skills

5.Be familiar with MS Office / Lotus Notes or equivalent / Veeva or other e-documentation system

6.Experience with the medical device/life science industry in an international company is preferred

7.Be proficient in English, both verbal and written

What we can provide 

---- Good place to work.

---- Attractive career path and growing opportunities.

---- A modern company who values people’s engagement with a work-life balance culture.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

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