Quality Assurance Project Support (SOP's) Aspect Resources
Published: 6th June 2019
Job Type
Sector
Consultant
Daniel Lowe
Salary
£40000 - £45000 Per Annum + Benefits

Description

Quality Assurance Project Support (SOP’s)

Location: Birmingham, West Midlands

Salary: Competitive + benefits

Duration: 12 Month Fixed Term

The Client: My client specialises in the research, development, manufacture and sale of innovative medical diagnostic products, instrumentation and materials

The Role:
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 companywide 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
Essential:

  • 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

Desirable:

  • 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
 

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