Edwards Lifesciences Sr Specialist, Tissue Quality in North Ryde, Australia
Ensure continuity and quality of biological tissue supply for Edwards to meet manufacturing demand and R&D requirements.
Key Job Functions
Maintain existing suppliers and Qualify new suppliers/viable sources of biological tissue, using qualitative audits and calibrations in keeping with regulatory standards (e.g. ISO standards, evaluation of tissues harvest area, packaging, tools etc). Identify any gaps with plans to remediate and follow through for closure.
Continuous Process Improvement: Identify gaps and provide resolutions, including retraining as necessary and any needs for equipment replacement are addressed. Inspect and audit domestic and international suppliers’ facilities, personnel involved in the management, processes of tissue harvest to ensure compliance with Edwards and regulatory requirements. Onsite facilitation for investigations to correct any quality issues.
Management of changes of suppliers (e.g. logging of change, communication with RA Partners, and oversight of change through closure) as well as cases of facility re-design and /or modification (e.g. movement of harvest facility or expansion) while partnering with vendor to ensure consistent supply of tissue.
Enhance metrics and score cards by implementing automated reports for real time reporting shared with supplier, to drive and improve performance.
Investigate complex adverse event resolutions in partnership with suppliers (NCRs, SCARS, etc.) and provide solution for implementation, while applying best practices.
Present tissue procurement program (e.g. SOPs, issues resolution and ongoing oversight) during internal and external audits.
Provide coaching and guidance to lower level employees.
Marginal Job Functions
Other duties as assigned by Leadership: Interface with USDA, FDA, Customs, livestock experts, and other government agencies (domestic and international).
Support other suppliers audit activities (Non-Tissue Suppliers), and other ANZ (Australia and New Zealand) QA business activities as requested by Quality Management.
Bachelor’s Degree in related field with 5 years previous related experience, required
Animal Science background, Livestock experience, ISO-22442-2 knowledge, helpful
Proven expertise in Microsoft Office Suite including Access, Excel, and Word, quality management system (QMS) and ERP (Enterprise Resource Planning) modules
Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
Demonstrated problem-solving and critical thinking skills
Ability to travel locally and internationally
Must be able to work in hot, cold, moist, and wet conditions in slaughterhouses, as well as seasonal conditions at feedlots
Full knowledge and understanding of Edwards policies, procedures and guidelines relevant to biological tissue
Full knowledge in purchasing and production operations in a medical device or other regulated environment
Full knowledge of slaughterhouse, feedlot, and livestock industry
Adherence and knowledge of relevant regulatory and quality standards and requirements
Strict attention to detail
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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
Must be a team player and adapt to Edwards culture and patient focused.
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.