Edwards Lifesciences Director, Quality in New South Wales, Australia
Manage team with responsibility for providing leadership in establishing, implementing, and maintaining Quality System processes and documentation in compliance with domestic and international Regulatory and Quality standards
• Manage a team with responsibilities to establish and maintain compliant and effective Quality Systems (e.g., CAPA, management review, documentation control, internal and external audit management, training, and complaint handling) including developing and managing budget. Drive a culture that is focused on quality and business results. Create an environment that fosters employee motivation and engagement.
• Develop robust talent development plan in alignment with functional growth strategies of the department.
• Identify complex quality issues and support timely resolution in collaboration with R&D, Manufacturing Engineering, Operations, Quality, and other departments.
• Lead in identifying risk, developing mitigation strategies, defining alternative solutions and resolving issues in collaboration with cross functional groups.
• Lead the development, implementation, and maintenance of training programs to ensure adequate training of personnel on Quality System processes and documentation.
• Lead the audit management process of internal inspections (e.g. FDA, Notified Bodies, and other regulatory authorities) including; timely closure of post approval commitments, responding to inspection/audit, and resolving open issues with regulatory agencies.
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related science or engineering field related experience in engineering required and skill levels exceeding the requirements of the previous level Required and
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry and/or related industry Required and
Demonstrated track record in management of quality systems, technical and/or engineering disciplines Required
Master's Degree or equivalent in in related fieldExperience working in a regulated industry Preferred
• Proven successful project management leadership skills
• Proven expertise in quality software systems and Microsoft Office Suite required
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of engineering procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Expert understanding of related aspects of quality engineering processes and/or systems
• Expert knowledge of company procedures and applicable domestic/international regulations and standards
• Expert knowledge of implementation and administration of Quality System processes used in medical device industry
• Knowledge of financial acumen as it relates to the business as well as quality engineering
• Demonstrated ability to manage teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business
• Serve as core partner to other managers in Business Units, Functional Groups, Regions and IT
• 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 work and excel within a fast paced, dynamic, and constantly changing work environment
• Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels
• 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
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.