Manager, Quality

Edwards Lifesciences; Kuala Lumpur; On-site; MYR 100,000 - 120,000; Full time

Job summary

A leading medical technology company seeks a Quality Systems Manager in Kuala Lumpur, Malaysia, to lead process improvements, manage supplier quality, and ensure compliance with Quality Management System requirements. Candidates must have a Bachelor's degree, 8 years in Quality, and strong project management skills. Proficiency in Quality systems and fluency in English are essential.

Qualifications

• 8 years of professional experience in Quality, preferably in regulated industry.
• Experience in a manufacturing site is preferred.
• Proven project management skills and expertise in Quality systems.

Responsibilities

• Identify and lead business process improvement solutions for Quality Systems.
• Manage Supplier Quality Processes including selection, qualification and audits.
• Administer and improve Training Compliance in GC APAC.

Skills

Project management skills

Advanced Excel

Documentation and communication skills

Negotiation and relationship management

Fluency in English

Education

Bachelor's Degree in a related field

Master's Degree or equivalent

Tools

Microsoft Office Suite

Quality systems

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
• 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
• Experience of working in regulated industry
• 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