Quality Assurance

**Join Us as a Quality Assurance & Regulatory Affairs (QARA) Coordinator - Powering Global Transformation**

Are you passionate about quality and compliance in the medical device industry? Do you thrive in a dynamic, global environment where you can influence change and build cross-functional partnerships?

We’re looking for a **Quality Assurance & Regulatory Affairs (QARA) Coordinator**to play a key role in our global **ERP (Enterprise Resource Planning) transformation program**. In this role, you’ll be the connector between Quality, Regulatory Affairs, IT, and Operations — helping ensure that our processes meet high standards across all regions.

**What You’ll Be Doing**:**✔ Aligning Quality & Regulatory Outcomes**
- **Support global QARA initiatives within the ERP transformation program.**
- **Collaborate with Global Process Owners (GPOs), SMEs, and functional leaders to align on regulatory and quality goals.**
- **Organize and facilitate QARA meetings to drive alignment, decisions, and accountability.**
- **Help harmonize Quality Management Systems (QMS) and practices across global sites.**
- **Contribute to the creation and updating of Standard Operating Procedures (SOPs).**

**Communication & Stakeholder Engagement**
- **Clearly communicate updates and decisions across various stakeholder groups.**
- **Tailor messaging to different audiences - from technical teams to senior leadership.**

**Cross-Functional Collaboration**
- **Work closely with global teams across different time zones.**
- **Foster strong partnerships between QARA and departments such as IT, Operations, and Procurement.**

**Risk Management & Compliance**
- **Identify and mitigate risks in alignment with QARA and program guidelines.**
- **Ensure regulatory and quality standards are met throughout the transformation.**

**Technical & Validation Support**
- **Support software implementation efforts, including Computer System Validation (CSV), traceability, and User Acceptance Testing (UAT).**
- **Be an active QARA voice in the Oracle Fusion implementation project.**

**Change & Continuous Improvement**
- **Support process and system changes while helping teams adapt to evolving practices.**
- **Promote a culture of quality, innovation, and improvement.**
- **Standardize tools and practices to increase global consistency and efficiency.**
- **Ensure ongoing compliance with relevant medical device regulations.**

**What You Bring**:

- **ERP Expertise: Hands-on experience with Oracle platforms (E-Business Suite, Fusion).**:

- **Industry Knowledge: Background in manufacturing, supply chain, compliance, and quality assurance—ideally in regulated industries**.
- Project Coordination: Skilled in supporting multiple teams, projects, and priorities.
- Self-Motivation: Independent, proactive, and capable of taking ownership.
- Collaborative Spirit: A relationship-builder who can bridge diverse teams and regions.
- Influence & Alignment: Strong ability to gain stakeholder buy-in and drive consensus.
- Communication: Clear, concise, and adaptable in written and verbal communication.

**Preferred Qualifications**:

- **Bachelor’s degree in Science, Engineering, or a related field.**:

- 5+ years of experience in the medical device industry, with knowledge of standards such as ISO 13485 and 21 CFR Part 820.

**Why Join Us?**:
You’ll be at the heart of a global transformation that’s shaping how our organization delivers value through quality and compliance. If you’re ready to elevate your impact and work on something meaningful with passionate professionals, this could be your next big move.

LI-APAC