Quality Assurance Project Support (Labelling)
Location: Birmingham, West Midlands
Salary: Competitive + benefits
Duration: 9 Month Fixed Term
The Client: My client specialises in the research, development, manufacture and sale of innovative medical diagnostic products, instrumentation and materials
Manage to completion the delivery of projects for the company which have significant Quality Assurance and/or Regulatory impact on requirements. These projects will have direct impact on business elements such as compliance, cost saving and/or process efficiency.
To ensure that company wide projects meet all requirements of relevant regulatory standards and Regulations: (ISO9001/13485, FDA 21CFR part 820 and QSRs).
To make suggestions as to how the QMS and business processes can be improved and how efficiencies can be made on previous experience and to implement approved changes.
This role will also be responsible for supporting business wide projects across multiple departments at the company.
Knowledge and Skills
- Working knowledge of FDA part 820, ISO13485, cGMP
- Experience of working within RA/QA environment within an IVD or medical device company
- Knowledge of the application of quality systems in manufacturing.
- Knowledge of Audit, Non-conforming Product and Corrective Action systems
- Good understanding of Quality principles/Quality systems and regulations for IVD/medical device company.
- Excellent stakeholder management skills: ability to build and maintain relationships with internal and external customers
- Leadership Skills: Proven ability to influence others and lead significant change.
- Strong communication skills
- Project Management
- Degree or equivalent in biological sciences or similar
- Quality Assurance background
- Quality Training to ISO9001 and/or ISO13485/21CFR Part 820
- Currently working in a similar role
To apply for this role please submit your latest CV or contact Aspect Resources on 0121794 8181