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 for Quality Management in compliance with regulation and Edwards Quality requirements (e.g., FDA QSR, ISO 13485, TWFDA) including rolling out Global SOP.
- Oversee Quality system performance.
- Collaborate with local team and planning internal 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.
- Partner with internal stakeholders to enable business sustainability and in managing Quality issues (e.g., NPI, Process change, Quality awareness, Customer inquiry).
- Provide direction and guidance to project teams to execute tactical Quality projects and/or initiatives in Korea.
- Ensure post market activities well implemented as per the requirement, including MDR, FCA. Resolve post market product quality issue, including hospital enquiry in partnership with stakeholders.
- Develop 3PL Quality capability. Develop supplier and dealer quality management strategies. Identify possible risks and plan all activities to enhance compliance to regulation and Edwards requirements.
- Lead and contribute to projects aimed at streamlining processes and practices through a globally or regionally harmonized and compliant approach.
What you'll need (Required):
- Bachelor's Degree in or higher in related field, 8 years of 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.
- Licenses and Certifications: ISO 13485 Lead Audit 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
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