Senior Quality Compliance Engineer, Jobs, Scotland, Glasgow, 5327

Engineering, Manufacturing & Supply Chain Recruitment

This vacancy is now closed

Senior Quality Compliance Engineer - Glasgow

Engineering & Manufacturing - Engineering & Manufacturing
Ref: 5327 Date Posted: Tuesday 13 Mar 2018
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Nine Twenty Engineering are assisting in the recruitment of a Senior Quality Compliance Engineer for our West Central Scotland based Client. Our Client requires an enthusiastic and skilled individual to be responsible for Providing guidance and support. 

The Role:

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 

Essential Skills and Experience:

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. 

If you have the skills and Experience required for this role please submit your CV  to Nicole Lavelle for consideration.