Edwards Lifesciences Quality Specialist in Netherlands
Support daily business operations from a Quality Assurance perspective to ensure compliance with internal and external regulations.
Support Quality System &Document Management System. Assist with creation and maintenance of departmentprocedure documentation.
Propose, execute and valuate(the appropriateness and effectiveness of) corrective actions.
Provide input, based onunderstanding of international standards and regulations, to businessunit/region and/or corporate quality initiatives including special projects,such as designing and/or recommending systems, procedures, etc.
Maintains a workingknowledge of all systems, procedures, and products pertaining to EdwardsLifesciences.
Collaborates withcross-functional teams to investigate issues, determining root cause, planningand taking actions. Track and manage NCR, CAPA and QA product hold.
Conduct and review CustomerComplaint Investigations, including root cause determination and actionsimplementation.
Conduct Device HistoryRecord review and final QA release for Edwards´ Devices. Would be approx. 40%of time.
Prepare and report variousquality metrics for the site and monitor those metrics for trends.
Other tasks and duties assignedby leadership
Working experience in a similar position for the medicaldevices / pharma is mandatory.
A good understanding of highly regulated industry with highquality level and operational components is required.
Solid computer skills in MS Office suite and ability tooperate general office machinery
Good written and verbal commination skills includingnegotiating and relationship management skills
Good problem-solving and critical thinking skills
Solid understanding of regulations
Eye for detail
Ability to build networks and interact with allorganizational levels and external parties
Must be able to work in a team environment, includinginter-departmental teams and representing the organization on specificprojects.
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Quality Specialist Location: Europe, Middle East, Africa, Canada (EMEAC)-Netherlands Job Number: 011934