Quality Engineer

SUMMARY

Ensure projects/products developed or sourced to meet applicable compliance and R&D specifications, Success Criteria and global product quality standards, by project quality management and implementing and continually improving Quality Systems, together with cross functional team and suppliers.

RESPONSIBILITIES/ACCOUNTABILITIES

1. Work with R&D, Global Regulatory and Packaging to minimize or eliminate quality risk in NPD, EPD;

And ensure the compliance from product safety certification, RoHS, REACh;

2. Manage the change and transfer without quality negative impact;
3. Drived by VOC, ensure Suppliers develop and implement effective and timely corrective action
4. Ensure the operation of EAST quality are compliant to the requirements of RB QMS manuals and procedures;
5. Arrange and carry out an audit program (ISO9001, ISO13485, GMP, applicable procedures) to EMOs and drive CAPA for the issues affecting product quality;
6. Ensure Quality is a key criterion for the selection of Suppliers

PROFESSIONAL QUALIFICATIONS

• Bachelor’s degree; major in Chemistry, Life Sciences, Pharmaceutics or other related.
• 2+ years’ experience in quality management in manufacturing site

SKILLS AND COMPETENCIES/PERSONAL ATTRIBUTES

• Fluency – written and spoken in English and Chinese (preferably both Mandarin and Cantonese)
• Good communication and presentation skills
• Problem solving in shop floor and reporting;
• Decent, self-motivated, open-mind, fast learner.
• Knowledge of relevant regulatory or medical device standards are preferred but not a must
• Experience of working in famous manufacturing companies will be an advantage

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.