Senior Quality System Engineer
Teleflex
- Kamunting, Perak
- Permanent
- Full-time
2. Improve on Complaints Management operation to enhance complaint operation and ensuring full compliance to standards and regulations.
3. Liaison with process manufacturing for complaint investigations, reporting and corrective actions.
4. Leads /support issue resolution with manufacturing and customer for complaints and related issues.
5. Owns review, approval and closure of complaints per timelines.
6. Owns timely respond to customer complaint queries and adverse event reporting.
7. Support the initiation and closure of HHE and EIF for site with Quality Systems Manager.
8. Preparation of quarterly, monthly and weekly reports for complaint for various updates of site, regional and global level. Review of all complaint data to ascertain quality of analysis.
9. Undertake effective OSH measures to ensure compliance within the workplace with the Occupational Safety and Health Act 1994 and other legislative requirements.Education / Experience RequirementsQualification :
Degree in Science or Engineering related field or EquivalentExperience :
Experience and knowledge Quality system requirements.
Good understanding in EN ISO13485, FDA QSR and MDD or EU MDR
Computer skills in Microsoft Office - at least at basic level for Word, Excel and Power Point
Good spoken and written English
Able to work independently with minimum supervisionSpecialized Skills / Other RequirementsNote: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.Teleflex is an equal opportunities employerTeleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.