Product Support Engineer

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 a relevant technical background, e.g. Engineering, Pharmaceutical or Life Science (organic Chemistry or applied chemistry 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, systems, and procedures applicable to the medical device industry
4. Basic data processing, statistical and analytical skills
5. Familiarity 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. Proficiency in English, both verbal and written

What we can provide

• Good place to work.
• Attractive career path and growing opportunities.
• A modern company that values people’s engagement with a work‑life balance culture.

This job description is intended to set forth the core functions required for this position and describe the general nature of the work to be performed. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Job duties, responsibilities and activities may change or be supplemented at any time as necessary. Kerecis is an Equal Opportunity Employer.