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