תיאור המשרה
Temporary position with potential for a permanent role
Responsible for maintaining the QMS, to ensure compliance with applicable regulatory requirements and standards.
The role provides quality oversight for key QMS processes, including CAPA, Complaint Handling, Internal Audits,, Document Control, Training Compliance, and supplier control.
Lead, monitor and coordinate CAPA activities from initiation through closure, including use of RCA methods.
Review, assess, monitor and process customer complaints, from the issuing to the closure.
Plan, monitor and manage the internal audit process.
Support supplier audits and external audit activities as required.
Assist departments in preparing for external.
Review quality system documents for compliance.
Support QMS training compliance and maintenance of training records.
דרישות:
Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
Certified Quality Engineer and auditor (CQE, CQA) or equivalent certification.
3-5 years of Quality Engineering experience in the medical device industry or pharmaceutical industry.
Experience with relevant standards (ISO13485).
Experience supporting FDA audits, ISO 13485 audits, MDSAP audits, or notified body audits.
Knowledge of statistical analysis.
Experience with Internal audit performance
Experience managing CAPA, RCA, complaints, audits, training and doc control processes.
Experience with supplier quality management and supplier remediation programs.
Experience with supplier audits and complaints.
Experience with RCA methods
Fluent English (written and spoken).
Proficiency in MS-OFFICE
ניסיון נדרש: 3-4 שנים