Quality Technician
BD
- Salamanca
- Permanente
- Tiempo completo
- Assure that Quality Notifications (QN) are crafted, investigated, completed and closed in accordance to the established Standard Operating Procedures.
- Identify quality events and support investigations. Report quality issues to Quality Manager.
- Support other associates or departments in the accurate follow-up, documentation and completion of complaints, changes, CAPAs, corrections and records.
- Monitor, document and analyze Quality Metrics.
- Capture information for the Quality Management Reviews, for the preparation of reports and other department activities.
- Draft and update local SOPs or working instructions, analysis reports, plans and other quality documents.
- Support the Quality department in audits (external, internal and customer) and other investigations from regulatory agencies, Notifies Bodies, and customers.
- Act as a role model for Quality by the daily representation of all quality aspects and modeling and emphasizing quality in the workplace.
- Keep abreast of the basic requirements for compliance and align with those requirements. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.
- Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
- Bachelor's degree or equivalent experience (preferred Life Sciences)
- 1 year relevant technical experience in a regulated industry or a combination of equivalent education and experience.
- Experience with ISO 13485 and/or ISO 9001 standards
- Knowledge of Good Manufacturing Practices (GMP)
- Upper intermediate Level of English