Company: Evolve Selection
Closing Date: 17 Dec 16
Salary (£): Competitive
Benefits: Salary commensurate with experience + excellent benefits package
We are recruiting for a market leading Healthcare organisation with a new opportunity working as a Quality Assurance/CAPA Engineer. This role will be working from our client’s head office in Essex on a fixed term contract for 12 months. The successful candidate will provide technical support, guidance and discipline for medical device manufacturing, engineering and distribution, in the areas of Quality Assurance, Regulatory Compliance, and Quality Systems Requirements.
We are currently recruiting for a market leading Healthcare organisation with an exciting new opportunity working as a Quality Assurance/CAPA Engineer. This exciting role will be working from our client’s head office in Essex on a fixed term contract for 12 months. The successful candidate will provide technical support, guidance and discipline for medical device manufacturing, engineering and distribution, in the areas of Quality Assurance, Regulatory Compliance, and Quality Systems Requirements.
Experience of maintaining Quality Management Systems and procedures.
Planning and facilitation skills.
Understanding FDA QSR requirements.
Ability to communicate effectively both verbally and in writing.
Knowledge of CAPA.
Problem solving skills / rout cause analysis.
Risk assessments to ISO 14971.
Understanding of ISO 9001:2000/ISO 13485 & Medical Device Directive.
Knowledge of the application of measurement techniques.
Prepare and support regulatory submissions.
Carries out / co-ordinates internal and external auditing.
Prepare and support FDA 510k submissions.
Construct and co-ordinate risk assessments to ISO 14971.
Promote and develop quality awareness and improvement activities within all areas of the Company.
Create data summaries for analysis and trend identification.
Liaise with suppliers with regarding quality issues.
Support and liaise with internal departments regarding required corrective and preventative actions.
Conducts route cause analysis.
Conducts risk assessments.
Carries out evaluation of effectiveness of corrective measures.
Create and issue quality report / management review data.
Conducts complaints analysis.
Liaise directly with other departments on any other matters relating to the effective running of the department and the business as a whole.
Provide information, as requested for both internal and external auditors.
Reporting all major incidents, which could affect quality to the Quality/Regulatory Affairs Team Leader in a timely fashion.
Provide support and guidance on quality and regulatory affairs to other companies within the Group.
To be aware of the Company’s Health and Safety Policy and to ensure that any hazards and/or accidents are reported to a Health and Safety Representative as appropriate and to be aware of safety issues throughout the Company.
Role Specific Competencies:
Self-motivated but able to work as part of a team.
Logical approach towards problem solving.
Attention to detail.
Excellent communication skills with the ability to deal with people at all levels.
Organised with good attention to detail.
2 stage process
Salary commensurate with experience + excellent benefits package
Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions. Please do not hesitate to get in contact with us on 0113 457 0777.
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