Curran Daly + Associates
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 in engineering or a 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