Senior Quality Systems Engineer

• Management of assignment to relevant NCR’s, Deviations, CAPA’s and Complaints (as required) and conduct relevant meetings.
• Support and develop internal/external customer relations with regard to recommendations and guidance in relation to the QS procedures and processes.
• Prioritisation of work to meet daily business requirements and timelines.
• Generation and co-ordination of monthly/quarterly/as required metrics for Management Review.
• Improvement initiatives and continuous improvement of the Quality System to streamline the flow of processes.  This may be project related where appropriate.
• Ensure timeliness of activities for progression and closure with a demonstration of initiative to resolve issues/complaints, whilst maintaining effectiveness of the Quality requirements.
• Supervisory/deputising duties for other team members, as required.
• Document Control and Archive Control.
• Support and perform training elements of the Quality System, as required.
• To adhere to the Rules and Regulations of the company as laid out in the Staff Handbook.
• All other essential related duties as required.

Essential:

• Diploma level Science/Engineering/Quality orientated qualification
• Minimum experience working in a QA/QS environment within the medical device or pharmaceutical industry.
• Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC
• Knowledge of FDA QSR Part 820
• Computer literate to include MS Word, Excel and MRP

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:

Desireable:

• GMP and audit qualifications
• Experience of handling and investigating a high volume of CAPA/Investigative/

Quality Project activity.

• Analytical skills
• Knowledge of other country specific regulation (eg Canada, Japan, Australia).
• Supervisory experience.
• Planning, control and organisational skills.
• Ability to work with minimal supervision and use of initiative.