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QA Engineer – Compliance QM (Maternity Leave Replacement) at Mego Afek

Kiryat Bialik, Haifa District, Israel -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QMS Maintenance, CAPA Management, Complaint Handling, Internal Auditing, Document Control, Training Compliance, Supplier Control, Root Cause Analysis, ISO 13485, FDA Audit Support, MDSAP Audits, Statistical Analysis, Supplier Quality Management, English Fluency, MS Office

Industry

Medical Equipment Manufacturing

Description

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. Requirements 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

Responsibilities

Maintain the Quality Management System to ensure compliance with regulatory requirements and standards. Provide quality oversight for key processes including CAPA, complaint handling, internal audits, and supplier control.