SURGICAL INNOVATIONS

Responsibility

• health and Safety
• reporting of hazards, unsafe conditions, and near misses, ensuring that all related actions are implemented across site in a timely manner
• manage all equipment introductions to site, ensuring compliance with the relevant safety standards
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• ensure all new processes, equipment, products are risk assessed before putting into operation
• participation in the H&S Committee and leading Safety Gemba walks, ensuring actions are implemented as necessary
• ensuring relevant health and safety is maintained for all areas of responsibility and ensuring that all work is completed in a safe manner and comply with relevant safety legislation and site policies
• ensure that the Calibration procedures are followed, that the impact of previous results from items out of calibration are reviewed and suitable actions taken, and that the calibration process does not impact the production plan
• overseeing the Site Master validation plan and all associated validation activities
• ensure that the team follow the CAPA, CCF and Customer complaint procedures and that actions are implemented in a timely manner

Earnings for position manufacturing manager

Responsibility

• role: Skilled CNC Machine Operator
• hours: 34 hours per week/4 days per week/Rotating shifts
• location: Clayton Wood Bank, Leeds, LS16 6QZ
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• overseeing the completion of jobs by loading and operating the machinery, ensuring visual inspection and SPC checks are performed throughout the operation

Requirements

• must be able to work as part of a team and on their own initiative
• CNC setting
• demonstrate good housekeeping practices
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• ensure all health and safety practises are adhered to
• metrology knowledge in the use of micrometres / verniers / all gauging
• experience on sliding head lathes
• fanuc programming experience
• apprenticeship Trained
• CMM experience
• knowledge of lean / continuous improvement exercises and identification of cost reduction opportunities

Responsibility

• participate in Safety walks and ensure actions are implemented in a timely manner
• conduct layered process audits
• conduct return to work interviews and documentation
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• management of non conforming product in the machine shop
• ensure the that control checks and necessary actions are completed
• ensure that Risk & COSHH assessments are up to date and that the team are trained against them
• carry out 1:1 meetings and appraisals with the operators

Requirements

• in depth knowledge of CNC programming and machine setup
• clear understanding of Metrology and Measuring Equipment
• experience of a leadership role within a machine shop environment
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• microsoft software
• great communication both written and verbal
• excellent time management skills
• CNC Programming software experience
• understanding of machine maintenance and repair
• experience of implementing a 5s culture
• knowledge of Lean Principles

Responsibility

• supports Quality with investigation of complaints, NC and CAPA. Carrying out root-cause analysis, identifying and implementing permanent solutions
• assisting with the implementation of corrective actions following customer complaints and both internal and external NCR’s

Requirements

• engineering Degree or a minimum of 3 years related industry experience
• strong experience of measurement/inspection activities
• experience with GR&R
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• good time management
• experience of Process and Product Improvement and Validation within regulated environments ideally Medical Device or, automotive, oil & gas, aerospace, pharmaceutical industries

Responsibility

• lead on assigned projects to improve quality/regulatory compliance
• manage distribution quality issues with key stakeholders to ensure timely resolution
• review and approval of NPD related documentation
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• manage & develop the QA team to ensure all compliance requirements are met and adequate cover is maintained
• complete trend analysis, reporting and presenting of Quality data at all levels and specifically for management review
• develop, improve, and write new processes and SOPs as required

Requirements

• minimum 2 years’ experience in leading a team
• excellent communicator and able to collaborate effectively with others
• strong organisational skills with a keen eye for detail
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• working Knowledge of EU Medical Device Regulation, MDSAP country specific regulations including, FDA regulations , Canadian Medical Device Regulations and other international regulations
• minimum 3 years’ experience in Quality Assurance, working to the requirements for international quality systems for a medical device company, including ISO 13485