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Senior Quality Engineer - Lancashire

Ref: 208 Date Posted: Thursday 12 Jul 2018
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Summary of position 
Part of the Quality team reporting to the Quality Manager, QC & QE. This role provides Quality Engineering support to site manufacturing processes by maintaining and developing the Quality System. This includes the procedures and records required for the development, validation and production of the clients' products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 9000, ISO13485, FDA QSRs and the Medical Devices Directive. 

Duties & Responsibilities (leadership, people development, planning and execution) 
• Perform monthly trending of all NCs that arise within designated production processes. 
• Generate such data as is required for Dashboard reviews as they apply to designated production processes. 
• Ensure all assigned quality actions are investigated, have causes identified and actions plans completed to the agreed schedule, regardless of source. 
• Perform Internal Audits to schedule and complete audit reports and effectiveness reviews. 
• Lead investigations into product or process issues raised within designated production processes, identifying root cause and corrective action plans as required. 
• Partner with Engineering team during the definition and introduction of new or improved processes, ensuring all validation, calibration, risk management and documentation activities are completed. 
• Complete Periodic Validation Reviews and Process Monitoring & Control (Relating to ongoing process verification) 
• Support operations and engineering teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule. Ensure that Critical System Changes are raised for all applicable changes. 
• Work with operations and engineering teams to ensure that process improvement activities including Lean Manufacturing activities are identified and introduced in a compliant manner. 
• Quality Leader within assigned Value Stream 

Quality and Compliance Related Responsibilities 
• Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations. 
• Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance. 

Job Specific Competencies 
• In-depth knowledge of Good Manufacturing Practice. 
• In-depth knowledge of quality systems and techniques including ISO 13485 and FDA QSRs. 
• Knowledge of Quality toolbox including FMEA, Mind-Map, Root cause investigations, Lean and Six Sigma tools & techniques. 
• Computer literate. 
• Basic Statistical knowledge to apply to operational improvements/investigations. 

• Minimum of degree in scientific discipline. 

• Minimum of 3 years in a quality, technical or manufacturing role in a regulated industry. 
• Well-developed organisational skills with an ability to work independently. 
• Working knowledge of ISO9001, ISO13485 and FDA Quality System Regulations an advantage. 

Personal Attributes 
• Detail conscious 
• Excellent time-management 
• Good interpersonal skills 

Specific Technical Skills 
• Focus on achievement and delivery of results 
• Versatile – readily grasps technical detail outside own speciality 
• Well organised, can cope with a number of competing projects and activities 

• Must have experience of working to International Quality Standards such as FDA and ISO. 
• Use of Microsoft Office suite including Word and Excel for generating reports. 
• Good written and verbal communication skills. 

• Use of Microsoft Office suite including Project. 
• Lean Manufacturing application

Specialists in consultancy

At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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