Description
My client is in the middle of an exciting period of growth and investment, the company have now created a new position for an experienced Quality System professional to manage the activities of the QA to assure the company will meet all quality assurance / ISO 13485 regulations. They are looking for an enthusiastic, self-motivated, highly organised and flexible person to join the team on a full time basis.Core Responsibilities:
- Maintain an effective Quality Management System (QMS)
Managing Quality Assurance regulations to ISO 13485 - Experience of working within Medical Device Directive 93/42 and FDA QSR
- Ability to train internally on Directives and regulations above
- Qualified Lead Auditor
- Management of CAPA and complaints systems
- New Product Introduction, support and oversight
- Liaise with and host audits by notified bodies, competent authorities, regulatory authorities and clients as required
- Manage company audit programme
- Regulatory input and support registration activity for new products
- Design Control experience -
- QMS keeper
Essential Requirements;
- 5+ Years of Quality Assurance experience in a Medical Device company.
- 3+ Years in a Quality management position.
- Excellent understanding of the management of an ISO 13485 Quality System.
- Engineering and Manufacturing backgrounds would be an advantage but not a necessity.
- Great interpersonal and time management skills.
My client is looking to move quickly on this position so if you believe you have the required experience and are looking for a challenge in a rapidly expanding company then send me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com