Responsibilities:
-Maintain compliance of QMS in the manufacturing site including leading and/or carrying out CAPA.
-Preparing and updating QMS work instructions and process specifications in the manufacturing site
-Control over quality of products including testing in the in-house lab
-Carrying out, supporting process and product validations
-Lead and/or carry out the continuous improvements in the manufacturing site from quality, regulatory and business perspective
-Assign and directs work activities for the team, while ensuring accountability for decision making and appropriate cross-functional communication

Qualifications:
-Bachelor degree in engineering master degree is preferred. Profound knowledge of ISO13485, 21 CFR Part 820 Internal Auditor
-Very good English spoken and written
-Knowledge of MDD / MDR and FDA regulationsLead Auditor experience. Project Management Leadership Experience,
-Over 5 years’ experience as quality Specialist or Manager in sterile medical devices areaExperience in QMS procedures Profound knowledge of manufacturing processes and experience in validations
-Successful record of product launches and co-operation with R&D,
-Records of unassisted successful product certification under MDD or FDA.
-Experience in clean room environment requirements
-External auditing experience
-Experience in leading international teams understands business needs strategic.

The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world.  Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices.      Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices.  Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team.  The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.

http://www.sol-m.com