A fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. 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
Direct Manager: Manufacturing Quality Manager
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
Personality:
Team player ,Excellent interpersonal relations, Highly organized and detail oriented, Motivated and committed ,Creative and proactive.
Assertive with the ability to effectively lead and drive cross-functional collaboration; capable of confidently interacting with multiple departments, assigning tasks, and ensuring timely execution.
This position is open to all candidates.