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Quality Director Emea
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**Role Purpose**:
Provide expertise in utilizing quality principles and methods to develop and oversee quality projects and activities.
Contributing for Quality EMEA success by working collaboratively with the Business senior leaders, managers and staff to create and maintain a quality culture consistently delivering high-quality, effective and safe products, services and solutions. Be the leader for regional Business complaints and NPI / NPD, transforming quality relationship with commercial to increase customer focus and become a true business partner
**Job Functions**:
- Act as Quality EMEACLA Business Partner within the Quality international organization: Ensure successful achievement of Quality objectives including leading in identifying risk, developing mitigation strategies, defining alternative solutions and resolving issues in collaboration with cross functional groups.
- Transform supply chain and quality relationship with commercial to increase customer focus and become a true business partner by:
Develop 24 hrs launch process in Europe, aligned with the NPI / NPD global guidelines
Partner with distributors and implement quality system related to distributors model, including clear visibility on performance
Elevate quality to strategic partners with commercial and create visibility on performance, including providing direction and guidance to project teams to execute larger Quality and strategic projects, initiatives and/or programs with accountability for successful completion of all project deliverables, with dotted line relationships
Clarify roles and responsibilities between global vs local and among Quality functions and implement it
Define and implement effective communication channels between complaint handling international and the regional business leadership team, effectively helping measuring and control product and business risks and ensuring customer satisfaction, including dotted line relationship
Lead the development, implementation, and maintenance of training programs to ensure adequate training of personnel on Quality System processes and documentation.
Develop long-term Quality strategies.
**Education**:
**Master's degree with**:
related experience in engineering required and skill levels exceeding the requirements of the previous level
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry and/or related industry
Demonstrated track record in management of quality systems, technical and/or engineering disciplines
Experience working in a regulated industry
Certification in related discipline (e.g. ISO 13485/Lead Auditor, Six-Sigma Black Belt/Green Belt, ASQ Certified Quality Engineer (CQE)) preferred
**Required skills**:
Proven successful project management skills
Proficient in Microsoft Office Suite and related tools and systems
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Excellent problem-solving, organizational, analytical and critical thinking skills
Excellent facilitation and presentation skills
Recognized as an expert in own sub-function(s) and/or area(s) within the organization with broad-based advanced knowledge within the organization
Expert 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
Ability to manage competing priorities in a fast paced environment
Represents leadership on projects within multiple areas, interfacing with project members and stakeholders
Consult in project setting within multiple Quality-related areas, interfacing with stakeholders
About Edwards Lifesciences
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 13,000 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.
COVID Vaccination Requirement
**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
EEO is the Law click here for more information regarding Equal Employment Opp
