Senior Quality Assurance System - Medical Devices
Great Growth Opportunity
International Biomedical Company
Il nostro cliente
Manufacturing Biomedical Company
La figura ricercata
Reports to the Quality Assurance Manager, the Senior Quality Assurance Specialist will be supporting product quality / Quality System activities within different production plants (including plastic moulding, Assembly in Cleanrooms ISO-8) and outsourced activities such as extrusion with different materials including silicone.
- Ensure that the processes required for the Quality Management System are established, implemented and maintained up to date
- Deploys quality strategies and approaches; key partner in implementing all department and site strategies.
- Monitor Processes and Metrix including performance indicators to monitors and drives department progress against goals and objectives.
- Qualification and monitor of suppliers of products and services concerning the manufacture and control of Medical Devices, and keep up to date the evaluations.
- Ensure that internal Audits and Audit to suppliers are carried out according to the plan
- Ensure that training is carried out as per the annual plan
- Support on manage failure investigations related to potential field performance issues of product
- Support to manage quality discrepancies related to process and product; develops scope, disposition, and corrective actions for prevention of future discrepancies;
- 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;
- Works cross-functionally in identifying and resolving technical issues. Contribute to solving technical problems by coordinating and facilitating sessions in collaboration with the various stakeholders;
- Collaborate with the Regulatory team to ensure compliance with company policies & Medical Devices Standards/Laws.
Participate to New Product Development Programs Particularly Design Transfers / Change Management activities.
Il candidato prescelto
- Bachelor's degree (engineering, a technical field or equivalent)
- 3+ years of experience in working in Quality Assurance related area.
- Experience working in a regulated industry (Medical Device, Pharma, Aerospace, etc
- Knowledge of Quality System principle such as ISO 9001, ISO13485, CFR820.
- Auditing experience preferred
- Experience with performing Root Cause Analysis, Change Control and Validations (IQ, OQ,PQ) is preferred.
- Business improvement methodologies such as Kaizen, Lean, Six Sigma models certification preferred
- Leadership, initiative and accountability;
- Impact and influence;
- Excellent computer skills including Word, Excel, Power Point and Visio
- Experience in preparing data and charts for Management
- Excellent organizational skills, analytical abilities, and ability to multi-task
- Occasional domestic travel required
- Fluent in Italian and English both written and spoken.
Cosa comprende l'offerta
The salary package will be proportionate to the candidate's experience