Quality Assurance Engineer - Medical Device

Description

Support Incoming inspection, in process and final acceptance tests activities in production

• Support and control of production and process controls of environment monitoring activities

• Responsible on production batch files review and final release prior distribution

• Support risk management activities including planning, design & mitigations of production risk analysis,

and overall risk summary reporting (according to ISO14971).

• Support transfer to manufacturing activities both in product development (NPI) and as well as sustain of

released production line(s).

• Responsible on elements of Quality System, including but not limited to, CAPA, production validations,

equipment qualification [IQ, OQ, PQ], nonconforming materials (MRB), design changes, leading and

investigating production and environment process failures and etc’.

• Support external and internal audits activities on site, drives site readiness activities.

• Work closely with company suppliers on qualification of new parts and processes related to product

development.

Qualifications (Education, Skills, and Experience; Required):

• Bachelor’s degree with 1-3 years of professional experience in Medical Devices.

• Knowledge and experience with: ISO 13485, QSR 820, ISO14971 and MDR.

• Ability to work effectively in a changing and multi-tasking environment.

• Good verbal and written communication skills with English fluency – Mandatory.

• Experience with electronic document control system [DOT Compliance Suite] – advantage.

• Strong design/quality engineering skills with a proven track record in all process validation, equipment

qualification, calibration, design transfers, environment controls and production/process risk

management are strongly preferred.