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.
Skills Required
- Bachelor's Degree with at least 2 years' QA experience
- Experience in medical devices and related industry
- Strong communication skills in English and Mandarin
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Retirement Support — Retirement programs include a 401(k) match complemented by a separate profit‑sharing contribution. These elements add meaningful long‑term value to total compensation.
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Equity Value & Accessibility — An employee stock purchase plan with a discount and look‑back feature, alongside stock awards for eligible roles, provides notable upside. Program expansions indicate continued accessibility.
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Leave & Time Off Breadth — Time‑off policies include generous PTO, company holidays, and a year‑end holiday shutdown. These offerings enhance work‑life support when available at the site.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
