Quality Engineer Medtech (m/f)

REFERENZNUMMER:

327193/10

IHRE AUFGABEN:

-Provide oversight of Q&R Manufacturing New Product Introduction (NPI) projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on quality system status of projects on manufacturing department or site level.
-Ensuresthat appropriate quality plans are made and a suitable quality system is in place, for both New Product Introductions (NPI’s) as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System (QS) design
-Review calibration plans and records, environmental controls
-Assess the effectiveness of the QMS linked to production controls
-Approve which processes need validation/re-validation after changes, and verify processes and plans/records
-Accountable for ensuring Manufacturing quality systems are established, maintained and documented according to needs of the business, customers and applicable quality system standards ®ulations
-Support problem analysis and establishing corrective action (CAPA)
-Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems
-Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.)

IHRE QUALIFIKATIONEN:

-Engineering degree
-Familiar with international quality system requirements (preferably FDA’s QSR & ISO 13485)
-Demonstrated effectiveness in independently investigating problems and moving them towards resolution
-Organised/structured work approach
-Strong English and German communications skills, written and oral
-High reliability and quality focus
-Demonstrated project management skills
-Education/Experience in the quality, compliance or regulatory area, preferably in a healthcare environment
-Knowledge of quality tools/techniques and analysis methods
-Experience in an international environment

WEITERE QUALIFIKATIONEN:

Quality manager