Manager, Quality

Edwards Lifesciences

Malaysia, Kuala Lumpur

8-10 Years

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Posted 2 months ago
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Job Description

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:

Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiencies, and user experience
Act as GC APAC Supplier management Lead; providing expertise guidance and support to GC APAC to achieve compliance in Edwards Supplier Quality QMS requirements
Manage GC APAC Supplier Quality Processes which include selection, qualification, audits, approval, communications, Non-conformance management and partners with Operations to ensure the process meets established procedures
Partner with APAC Country Quality and commercial team - provide dashboard trending, analysis and solutions on Post Market Surveillance
Plan Quality System projects and activities with accountability for successful completion within scope of project deliverables
Administer and improve the Training Compliance of the GC APAC and ensure that relevant training is assigned and completed by stakeholders, which includes leadership team in the Region
Coordinate the training/ development needs for International Quality in GC APAC with respective country leaders. Develop yearly training/ development plan and execute accordingly
Review, identify actions and/or provide support to Quality leader holistically to achieve Metrics Target
Train, coach, and guide lower level employees on routine procedures. Provide input and mentorship for lower level employee's development plans
Provide input and mentorship for lower level employee's development plans
Other incidental duties assigned by immediate superior or VP, Quality

What you'll need (Required):

Bachelor's Degree in or related field, 8 years of professional experience in Quality Required and

Experience Of Working In Regulated Industry Required

Master's Degree or equivalent Experience in a manufacturing site Preferred

What else we look for (Preferred):

Proven successful project management skills
Proven expertise in both Microsoft Office Suite, including advanced Excel and Quality systems
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
Extensive knowledge in process validation and risk management
Extensive understanding of Quality Systems, National regulatory requirements
Extensive knowledge in ISO 13485, 21 CFR 820, 21 CFR 11, the relevant regulatory requirements in country, and all other applicable requirements.
Experience of FDA Inspection / Local Inspection preferred
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Fluency in English language required; other additional language preferred
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

More Info

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About Company

Edwards LifesciencesJob Source: www.linkedin.com

Job ID: 144851223

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Last Updated: 24-05-2026 07:43:59 PM

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