Qa-Qms Engineer

Job Description This role will focus as a Quality Representative, QS Quality Improvement Team, Basic QMS Role, Quality Representative QA CSS
What you will do Ensure the medical device regulatory compliance for the products released to market. Support APAC countries with Customer facing activities Continuous improvement and streamlining of processes across APAC to meet business needs. Screening Sales force cases to ensure customer feedback is processed correctly and trends and issues can identified as required. To support all APAC regions. To closely monitor Salesforce cases (and other sources) for new product launches in APAC countries and provide necessary information pre and post-launch to country BQ. To document and maintain customer return processes for all APAC countries to ensure full transparency. To help/coordinate the documentation and maintenance of local Regulatory requirements overview list and follow up / support countries in assessment and action required in cases of changes. This does include local labeling requirements. To ensure a transparent and clear overview of local (APAC) affiliate requirements to run the business (such as manufacturing license/ certification requirement as well as customer requirements/ license) and to ensure and ensure data are up to date to avoid any business disruption in alignment with local BQ person in charge. Prepare data input for local QIT meetings within APAC affiliates (focus customer-related topics) in alignment with the local BQ person in charge
Add Hoc:
- to support the local BQ team on-site as required. E.g. audit prep etc.
- personal development/training Experience At least 3 years experience in QMS of Medical Device Manufacturer. Bachelor's Degree of engineering or related field Good communication skills Experience in working with colleagues across APAC (including Japan, Korea, India, China, SG, ANZ, but not limited to the Proficient in Microsoft programs (Excel, etc) At least 3 years experience working in a team. Department: Quality
Role: Business Quality
Locations: Biñan, Laguna