Quality Assurance / Capa Engineer

This specialised technical moulding company manufacturing medical devices requires an experienced Quality Assurance/CAPA Engineer.

Main Job Purpose is as follows:
To support the organisations to meet is quality / regulatory requirements.

The administration and maintenance of the CAPA and Internal Audit process.

Provides technical support, guidance and discipline for medical device manufacturing, engineering, and distribution, in the areas of Quality Assurance, Regulatory Compliance, and Quality Systems Requirements. Uses root cause analysis to address problems and identify trends.

„X Support the Quality Manager to ensure that the companies maintain certification and product regulatory approvals.
„X Support the preparation and maintenance of the necessary documentation for product approvals in order to facilitate sales of medical devices in the UK and other foreign markets.
„X Maintain and organise the Internal Audit plan including vendor approval.
„X Maintenance and administration of the CAPA system
„X Carry out Internal audits and external supplier Audits.
„X Support and facilitate continuous improvement initiatives.
„X To ensure all identified non-conformances are recorded and administrated within the organisation internal audit process.
„X To support the analysis data for trend identification.
„X Support the QMS for all quality and regulatory issues.
„X Carry out CAPA investigations.

Core Competencies

„X Experience of maintaining Quality Management Systems and procedures.
„X Self-motivated but able to work as part of a team.
„X Internal auditing.
„X Excellent communication skills with the ability to deal with people at all levels.
„X Organised with good attention to detail.
„X Planning and facilitation skills.
„X IT skills.
„X Logical approach towards problem solving.
„X Communication skills.
„X Attention to detail.
„X Teamwork.
„X Flexibility.
„X Understanding FDA QSR requirements.
„X Ability to communicate effectively both verbally and in writing.
„X Knowledge of CAPA.
„X Problem solving skills / rout cause analysis.
„X Risk assessments to ISO 14971.
„X Understanding of ISO 9001:2000/ISO 13485 & Medical Device Directive.
„X Knowledge of the application of measurement techniques.

Key Tasks

„X Prepare and support regulatory submissions.
„X Carries out / co-ordinates internal and external auditing.
„X Prepare and support FDA 510k submissions.
„X Construct and co-ordinate risk assessments to ISO 14971.
„X Promote and develop quality awareness and improvement activities within all areas of the Company.
„X Create data summaries for analysis and trend identification.
„X Liaise with suppliers with regarding quality issues.
„X Support and liaise with internal departments regarding required corrective and preventative actions.
„X Conducts route cause analysis.
„X Conducts risk assessments.
„X Carries out evaluation of effectiveness of corrective measures.
„X Create and issue quality report / management review data.
„X Conducts complaints analysis.
„X Liaise directly with other departments on any other matters relating to the effective running of the department and the business as a whole.
„X Provide information, as requested for both internal and external auditors.
„X Reporting all major incidents, which could affect quality to the Quality/Regulatory Affairs Team Leader in a timely fashion.
„X 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.