Quality Engineer CAPA/NCR - Based Glasgow




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Reference: 6230

* This Vacancy Has Now Expired *

Evolve Selection are currently recruiting for an exciting new opportunity with a dynamic and supportive Healthcare organisation. Our client has an extensive product range within the Vascular market. This exciting role will be working as a Quality Engineer CAPA/NCR based in Glasgow. The main purpose of this role is to provide Quality Engineering support to the CAPA / NCR process including development of containment plans / investigation plans / root cause analysis / action plans / effectiveness plans and perform CAPA / NCR trend analysis.

Relevant Science / Engineering degree.
Six Sigma qualified – minimally Green Belt level.
Knowledge and understanding of applicable regulations especially with regards to NCR / CAPA processes and Root Cause Analysis/Trend Analysis.
Class III medical device knowledge (desirable).
Proven experience of working in a global company within a regulated industry, preferably Medical Device or Pharmaceutical manufacturing.
Working knowledge of Minitab or similar statistical tool.
Experience of FDA regulations.
Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for Medical Devices.
Strong analytical and problem-solving skills, including appropriate use of statistical techniques.
Excellent facilitation, coordination, prioritising, and communication skills.
Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment.
Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department.

Role Responsibilities:
Provide guidance and support for effective investigation and root cause analysis for new CAPAs / NCRs, working collaboratively with other functional areas as appropriate.
Provide guidance and support for effective implementation of corrective/preventive actions from CAPA / NCR investigations.
Provide guidance and support for robust effectiveness measurement of CAPA / NCR actions.
Support development of solution verification tools to validate CAPA / NCR corrective/preventive action plans.
Working with other functional areas as appropriate, ensure appropriate containment actions are defined and communicated.
Generate and maintain trending data for the CAPA / NCR process and publish as part of QMS KPI dashboard. Provide trending data and reports upon request to senior management, Functional Managers, regulatory authorities and customers.
Provide data trending information and CAPA / NCR status updates to the CAPA / NCR Review Board.
In conjunction with the Risk Team, provide QE input to dFMEAs and pFMEAs, particularly with respect to CAPA / NCR data.
Work towards meeting departmental and facility objectives.
Participate in facility Internal Audit programme.
Development of cross-functional and collaborative relationships within the facility.
Development of effective internal relationships to ensure quality and regulatory compliance for the business

Role Specific Competencies:
IT literate with strong analytical skills.
Flexible “can do” attitude needed to thrive in a fast-growing company.
Innovation, tenacity and drive to ensure success.
Self-motivation, persuasiveness and competitiveness.

Recruitment Process:
2 stage process.

Flexible salary and benefits DOE.

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.

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