Ta lista zawiera jedynie kraje, dla których opublikowano oferty pracy w wybranym języku (np. we francuskiej wersji wyświetlane są tylko oferty pracy napisane po francusku, a w angielskiej – tylko te po angielsku).
We're looking for people who embody our values, aren't afraid to challenge, innovate, experiment, and move at a fast pace. We're always looking for ways to improve our products and ourselves. If this is you, we'd love to talk.
Obowiązki:
Provide a timely follow up and communication on all supplier related quality issues (NCs / SCARs) reported in production / incoming areas, following applicable procedures
Provide proper analysis, follow up and communication all supplier related customer complaints, following applicable procedures
Asure the completion of Supplier Audits and/or Supplier Surveys/Assessments, following Supplier Annual Monitoring Plan and applicable procedures
Participate during supplier selection-qualification and approval to provide required quality-related input/output, following applicable procedures
Provide support and/or actively participate in internal and/or external audits (FDA, ISO, Corporate)
Work with project teams to coordinate or implement supplier quality initiatives in the plant
Provide guidance on documentation associated with supplier qualification/approval and supplier-driven changes including supplier validations, supplier quality agreements, process controls, audits, and compliance to regulations and company procedures
Work with suppliers to improve processes and Quality Systems
Wymagania:
Bachelor’s degree in engineering or equivalent
2 years of experience on industry
quality experience on medical devices preferred
Experience in similar position (SQA)
Visa Laser
Demonstrate effective communication, presentation and influencing skills, fluidly bilingual English and Spanish required
Strong experience with supplier quality
Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification
Strong Microsoft Office skills (Word and Excel)
Strong working knowledge of statistical quality tools and statistical process control (SPC)
Process Validation Activities skills (IQ/OQ/PQ), preferred
Strong working knowledge of Quality System Regulations, ISO regulations (ISO13485 preferable), Risk Management, GMPs / GDPs
Preferred Knowledge on Foreign country (Japan, Brazil, Canadian, China, Europe) Medical Device regulations
Mile widziane:
Process Validation Activities skills (IQ/OQ/PQ)
Preferred Knowledge on Foreign country (Japan, Brazil, Canadian, China, Europe) Medical Device regulations
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