Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Quality Specialist position is a unique career opportunity that could be your next step towards an exciting future.
How you’ll make an impact:
- Local Product Quality Control and 3PL Management to ensure product quality and traceability
- Oversee product quality related pre-market and post-market processes, identify and escalate potential risks.
- Monitor 3PL quality performance, identify any gaps and recommend solutions to drive improvements.
- Maintain and enhance local product inspection and release process to prevent any defective products released to the market.
- Manage local Q hold and collaborate with relevant local stakeholders (e.g. Supply Chain, Business and Regulatory Affair).
- Implement Change Control activities with 3PL and local stakeholders.
- Oversee Quality system performance in Hong Kong and ensure achievement of quality objectives
- Monitor regulation changes and support deployment in EW for Hong Kong.
- Support the implementation of quality system processes and practices to be compliant with HK regulation and EW procedures.
- Handle customer inquiries and support complaint handling (follow-up investigation questions with sales, etc).
- Support a strong quality culture, support continuous training and quality awareness to local BU.
- Collaborate with the Business and Channel teams to review new distributor qualification materials, ensuring quality readiness and timely onboarding.
- Act as HK QA contact for regulatory authority, and support to execute any field corrective action (FCA) in HK.
- Other incidental duties.
What you'll need (Required):
- Bachelor's Degree with at least 2 years' QA experience.
- Experience in medical device and related industry.
- Strong communication skills with the ability to converse with English- and Mandarin-speaking stakeholders.
- Meticulous with a keen eye in identifying improvement opportunities.
What else we look for (Preferred):
- Strong documentation, communication, negotiation, and relationship management skills to drive objectives.
- Excellent problem-solving, organizational, analytical, and critical thinking abilities.
- Good facilitation and presentation skills with ability to manage competing priorities in a fast paced environment.
- Deep understanding of Quality processes, systems, and regulatory requirements.
- Specialized depth and breadth of expertise within area of work in the organization.
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.