Quality Assurance Specialist - Italy
Consultant Marta Llagostera
Date posted 13 de diciembre de 2016
Medical Device Company is hiring a Quality Assurance Specialist for Italy. This company is dedicated to impacting the lives of people in a palliative way. The successful individual will ensure the appropriate licensing, marketing and legal compliance of the medical product, in order to control the safety and efficacy of the device
Under the direction of the RA & QMS Manager, the Quality Assurance Specialist performs activities required for compliance to applicable quality management system requirements. The QA specialist is knowledgeable in the Quality Management System (QMS) requirements and application with the ability to implement, manage appropriate quality systems and practices. Interface cross functionally with operations, customer service, service, technical support, supplier management and purchasing and carry out QMS requirements.
The individual in this position must be capable of dealing appropriately with highly confidential and proprietary information and will be responsible for implementing quality management system improvements. This position will require the ability to multi task and support a diverse range of responsibilities in a professional manner.
- Complaints: As a member of the post market surveillance team receive, document and respond to complaints. Monitor investigations and ensure timely follow-up of actions. Gather facts and data. Ensure products are returned for investigation when available.
- MDR and Vigilance Reporting: Review complaints for report ability and communicate in a timely and effective manner with notified body and regulatory contacts.
- Internal Audit: Perform internal audits, create audit plans and reports. Follow up on resulting corrective action. Ability to manage internal audit schedule as needed.
- External Audit: Support external audits, including but not limited to, customer, notified body, FDA, company led and unannounced type audits.
- Corrective/ Preventative Action: Facilitate corrective action process to assure investigation, root cause determination, corrective action, and implementation of CARs are documented and closed in a timely manner.
- KPI (key performance indicator): Create KPI reports track and analyze data for trends. Report to management as needed.
- Quality Management System: Participates in initiatives as they relate to establishing compliance with QMS standards.
- Training. Coordinate training for new or revised procedures and quality system awareness as needed.
- Recalls/ Field Actions. Work cross functionally as needed to support field actions. Coordinates documentation and closure of field actions as required.
- Management Review. Support management, review generate KPI data.
- Subsidiary: Support QMS activities at subsidiary sites as needed.
- 2+ years’ experience in a regulated industry preferably medical device.
- Hands on in-depth knowledge of applying cGMP/ISO requirements.
You will need a Bachelor Degree in Life Sciences (Biochemistry, Biology, Biotechnology, Pharmacy, Chemistry). At least 3 years of experience in a similar position in Medical Devices Sector. Proficiency in English is essential. Availability to travel. It will be necessary: knowledge of European Regulation on Medical Devices and experience in acting as interlocutor with the public Health & Safety Agency.
If you believe you have the skills to take this role and be part of this amazing Regulatory Affairs challenge, please apply below.