Regional PMS Quality Engineer

What You Can Expect

Job Summary

• To monitor overall product complaint status across the region, run trending analysis with in country PMS team and push legal manufacturers/Complaint Handling Unit (CHU) to improve accordingly.
• Collaborate Field Action related and CAPA related activities across the region and report to/follow up with corporate team as needed.
• Monitor PMS related KPI in the region, including complaint origination, Adverse Event, MoH reporting, product hold, CAPA, etc.
• Communicate with oversea manufacturer/CHU for Complaint /recall/AE handling.
• Lead and coordinate regional project related to PMS improvement or efficiency improvement initiatives.
• To establish & maintain related SOP, WI and/or system to be consistence with relevant regulations and company/process requirements.
• To be responsible for participating in Global procedure discussions on behalf of APAC.
• Improve quality management system and document control to ensure compliance with internal and external requirements.
• To assist and support QARA Manager for all assignment on QA duties.

How You'll Create Impact

Principal Duties & Responsibities

• To be responsible for regional PMS related processed development, implementation and maintenance. (30%)
• To lead and coordinate regional PMS/QA related projects (20%)
• To be responsible for complaint monitoring and improvement follow-up. (20%)
• To be responsible for participating in Global procedure discussions on behalf of APAC. (10%)
• To support QMS and Document Control maintenance in the region. (5%)
• To assist and support QARA Manager for all assignment on QA duties. (5%)

This is not an exhaustive list of duties or funcitons and may not necessarily comprise all of the "essential functions".

What Makes You Stand Out

Expected Areas of Competence

• Good communication skill, teamwork and proactive attitude.
• Good problem-solving competence with project management experience.
• Effectively managing one’s time and resources to ensure that work is completed efficiently.
• Proactively participating as a member of a team to move the team toward the completion of goals.

Your Background

Education/Experience Requirements

• Bachelor or master degree in Medical Science, biology, pharmacy, chemistry or other science related major, QA engineering background will be plus.
• Above 5 years working experience in Post-market Surveillance of international Medical Device company
• Professional Regulatory Knowledge on Regulatory history, guidelines, policies, practices, requirements in a regulated industry. Especially on recall, adverse event (AE) regulation.
• Familiar with ISO 13485, QMS related regulation, Good Distribution Practice. ISO 13485:2016 Internal audit / Lead auditor certified will be plus.
• Computer skills and be proficient with commonly used software.
• Good at written and oral in English.

Physical Requirements

Travel Expectations

10%