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:
• Responsible to plan and execute Quality operations and related objectives to ensure an effective and efficient Quality Management System in place
• Identify and evaluate Quality related processes for continuous improvement, ensuring business is in compliance with regulatory, ISO 13485 and company requirements
• Responsible for Quality Management in compliance with regulation and Edwards Quality requirements (e.g., FDA QSR, ISO 13485, KR Medical Device Act), including rolling out Global SOP
• Oversee Quality system performance
• Collaborate with local team and participate in audit program
• Quality training program and CAPA program to ensure successful achievement of Quality objectives
• Lead all preparation and communications with internal and external parties
• Provide guidance to the business on Quality issues (e.g., NPI, Process change, Quality awareness, Customer inquiry, regulator’s enquiry)
• Support in the complaint management process (sample return, follow up with sales etc.)
• Warehouse Quality Management
• Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, Over-Labeled Products, and Returned Products
• Implement and track Quality Hold(Global & local) in 3PL
• Drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements
• Drive and execute rework activities
• Initiate and track internal complaints resulting from labeling non-compliance
• Perform first article inspection (FAI) for product distributed Asia Pacific market
• Communicate and ensure implementation of EW documents (Procedure, WI etc.) at 3PL
• Ensure compliance of post market activities as per the country’s regulatory requirements, including MDR, FCA. Resolve post-market product quality issues, including hospital enquiry in partnership with stakeholders
• Develop supplier and distributor quality management strategies. Identify possible risks and plan all activities to enhance compliance with regulation and Edwards requirements.
What you'll need (Required):
• Bachelor's Degree in or higher in related field (Bioscience Background), 8 years years experience working experience as quality at international companies in the medical device field
• In-depth knowledge of ISO 13485 standard and local regulation pertaining to GDP, MDR and recall. Required
• Other: in Pharm, medical device area Experience working in multinational healthcare companies Preferred
What else we look for (Preferred):
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good facilitation and presentation skills
• Strong oral and written communication in English
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of related aspects of Quality processes and/or systems, and regulatory requirements
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and team
• Ability to consult in project setting within specific sections of area
• 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
