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 Product 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.
Support for non-conformity investigations and assign effective corrective actions for NCMRs and ensure timely closure and documentation.
Conduct quality assurance activities such as data analysis and statistical evaluations, SOP review and approvals, audit preparation,
Act as the Design QA representative in R&D project meetings, review and approve project deliverables and documents in accordance with internal SOPs and applicable regulatory standards.
Participate in risk management and evaluation processes related to product development and design changes.
Participate in change control processes for both R&D and commercial products, ensuring quality compliance.
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.
Support for non-conformity investigations and assign effective corrective actions for NCMRs and ensure timely closure and documentation.
Conduct quality assurance activities such as data analysis and statistical evaluations, SOP review and approvals, audit preparation,
Act as the Design QA representative in R&D project meetings, review and approve project deliverables and documents in accordance with internal SOPs and applicable regulatory standards.
Participate in risk management and evaluation processes related to product development and design changes.
Participate in change control processes for both R&D and commercial products, ensuring quality compliance.
Requirements:
Education: B.Sc. in Biomedical\Biotechnology\Chemical Engineering
Job skills:
2 -5 years of experience in QA/RA, preferably with R&D projects, in a medical device or pharma manufacturing company
Deep knowledge in working according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
Auditor qualification – an advantage
Computer skills: Proficiency in Office products – Must
Language skills: Fluent English – Mother tongue level
Personality:
Team player
Excellent interpersonal relations
Highly organized and detail oriented
Motivated and committed
Creative and proactive.
Education: B.Sc. in Biomedical\Biotechnology\Chemical Engineering
Job skills:
2 -5 years of experience in QA/RA, preferably with R&D projects, in a medical device or pharma manufacturing company
Deep knowledge in working according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
Auditor qualification – an advantage
Computer skills: Proficiency in Office products – Must
Language skills: Fluent English – Mother tongue level
Personality:
Team player
Excellent interpersonal relations
Highly organized and detail oriented
Motivated and committed
Creative and proactive.
This position is open to all candidates.
