Quality Specialist

About the Company

At Cedic we offer solutions for living. Our diverse product portfolio, specialising in fluid delivery, is designed with the main objective of improving the patient's quality of life. That is why we continually invest in our people and facilities to remain at the forefront of innovation and responsive to market needs.

Main purpose of the job

The Quality Specialist performs both Quality System and Quality Assurance activities according to ISO 13485.

Main responsibilities and duties

Quality Assurance:

- Ensure the production batches compliance. She/he will be responsible for controlling the batch record documentation and executing the batch release on the ERP according to shipment planning. Supervise the request for additional analysis for sterilization and bioburden control and keep update the record of results
- Manage non-conformity and deviations through the investigation process and documentation analysis, assessing the risk and material disposition in collaboration with DQA and Engineering. She/he will drive also the root cause investigation involving the necessary functions and departments. Collaborate in management issues linked to sterilization process or to third-party assembly processes.
- Support on complaints investigation.
- Monitor corrective and preventive actions (internal and external) with the managers and provide them with the necessary support to ensure that corrective measures put in place are effective.
- Communicate and cooperate with other departments as required to solve issues.
- Manage and ensure the application of procedures in place for contamination control of clean room and facility (clean room validation, monthly analysis of clean room parameters, cleaning plan application, pest control, training staff on entry/exit procedure, etc..). Ensure the execution of the cleaning plan, pest control, and clean room validations.
- Manage the rework activities: track the reworks, participate in the risk analysis definition, define actions needed and supervise the effective closures.
- Support on New Product Development Programs Particularly Design Transfers /
- Actively managing Change Management activities.
- Review and approve quality and validation documentation (IQ/OQ/PQ, reports, specifications).
- Support auditing activities, internal or versus suppliers.
- Participate in quality improvement initiatives and cross-functional projects.
- Manage process non-conformance and supplier corrective action reports (SCAR), when necessary.
- Manage supplier quality activities and qualification processes.

Quality Management System:

- Maintain and improve the QMS in compliance with ISO 13485.
- Ensure that the processes required for the Quality Management System are established, implemented and maintained up to date. Support in streamline processes and update QMS documentation and procedure accordingly.
- Support creation and updates of procedures, forms, and records.
- Coordinate documentation and change control activities.
- Support internal and external audits and follow-up actions.
- Track and communicate quality performance indicators.
- Manage Training process

Key Competencies / Qualifications /Skills

- Degree in technical or scientific fields (pharmacy, biology, engineering).
- Previous experience of 2-3 years in quality assurance.
- Good knowledge of the main sterilization technologies with particular reference to sterilization with ETO.
- Good knowledge of microbiology and related sterility tests, bioburden, etc.
- Statistical technical knowledge.
- In-depth knowledge of standards and standards applicable to the type of activity of the organization (MDD 93/42/EEC, MDR, EN ISO 13485, 21 CFR 820, GMP).
- Experience in quality systems audit according to EN ISO 13485, 21 CFR 820, GMP.
- Aptitude to contact competent authorities, notified bodies, suppliers and partners of the organization.
- Strong leadership skills, coordinate and direct working groups, instruct and update staff.
- Ability to interface with the different departments of the organization.
- Knowledge of the most popular Computer systems.
- Excellent written and spoken Italian and English.