Pubblicato il 30/04/2021
- Biomedical Company
- Great growth opportunity
Il nostro cliente
Reporting to the Quality Assurance Manager, this position is accountable to define and monitor quality level of supplier and supplies, ensuring the integrity of components and products purchased from suppliers meet the specifications and requirements.
She/he will be responsible for supplier qualification and supplier monitoring. The candidate will foster cross functional support to implement process improvements and problem-solving effort for supply base, to focus on protecting and improving incoming product quality and services provided.
- Responsible for qualification of new suppliers, and definition of quality agreement
- Monitoring of existing suppliers and ensure continuously improve quality of suppliers and their deliveries.
- Ensure that the required delivery quality is achieved. Support selection of suppliers.
- Execute supplier audits and audit follow-up. Ensure that annual supplier qualification and audit program is performed according to the plan.
- Have controls and knowledge of supplier's processes that have influence on the quality of the products supplied.
- Drives quality improvement effort internally and externally (supply base)
- Be part in the investigation in case of non-conformity or products complaints.
- Manage process non-conformance and supplier corrective action reports, when necessary.
- Support in the definition of quality plan and quality requirements for incoming inspection.
- Support or conduct training at outsourced supplier's facility, when needed
- Proactive work with suppliers to minimize ongoing quality/performance issues.
- Define KPI for supplier process control and keep up to date
- Participate in the definition and development of process and procedures for supplier controls
Il candidato prescelto
- Bachelor's degree (engineering, a technical field or equivalent).
- 1/3 years of experience in working in Quality Assurance and production related area.
- Knowledge of Quality System principle: ISO13485, CFR820.
- Mandatory audit experience (preferred according to standard ISO 13485).
- Experience working in a regulated industry (Medical Device preferred).
- Experience with performing Root Cause Analysis, and Validations process (IQ, OQ,PQ) is preferred.Positive, accountable, and with a spirit of initiative.
- Ability to work independently
- Analytical, structured and problem-solving mindset
- Proficient working with Word, Excel, Power Point and eventual new tools.
- Experience in preparing presentations and charts for Management.
- Available for occasional domestic, European and international travels.
- Fluent in Italian and English both written and spoken.
Cosa comprende l'offerta
Great growth opportunity