We are looking for an excellent Production Quality Engineer to join the QA product team.
Job Description:
Serve as owner of the NCMR process: manage the end-to-end handling of non-conforming materials, products, and processes, including initiation, investigation and corrective/preventive actions in accordance with company procedures and regulatory requirements.
Monitor NCMR process including quality KPIs
Support for non-conformity investigations and assign effective corrective actions for NCMRs and ensure timely closure and documentation.
Perform / review Root Cause Analysis as part of NCMR process and assign relevant corrective actions.
Act as QA representative for Manufacturing Quality process
Conduct quality assurance activities such as data analysis and statistical evaluations, SOP review and approvals, audit preparation
Requirements: Education: B.Sc. in Biomedical\Biotechnology\Chemical Engineering
Job skills:
2 -5 years of experience in QA/RA, in a medical device or pharma manufacturing company
Deep knowledge in working according to Medical device regulations and GMP (FDA QSR 820, ISO 13485)
Auditor qualification - an advantage
Computer skills: Proficiency in Office products - Must. ERP systems, an advantage.
Language skills: Fluent English - Mother tongue level
This position is open to all candidates.