Quality-Assurance- Medical Device- 13485- Validation-Manufacturing- EngineerSRG are currently look for a Quality Engineer to join a Medical Device Company based on the South Coast of...
QUALITY ENGINEER - BIRMINGHAM - MEDICAL DEVICES - PERMANENT £COMP
SRG are working exclusively with a highly successful and world leading Medical Device company located in Birmingham. There are a number of new opportunities for Quality Engineers to join this exciting establishment and drive Quality through their manufacturing department.
The successful candidates will be involved in:* Ensuring that the quality management system in manufacturing meets all requirements ( ISO9001/13485, FDA CFR 820 part 21 , QSR's)* Ensure the company maintains compliance to external and internal quality system requirements. * Advise on quality related issues/ day to day issues. * Assuring that manufacturing processes are in compliance with ISO/cGMP Quality Management System to produce consistent quality product. * Responsible for identifying opportunities and supporting improvement and reduced variation in our manufacturing processes resulting in improved metrics such as Overall Equipment Effectiveness (OEE), Scrap reduction and ability to leverage increased quality for delivery performance improvements, etc.
Principal Duties and Responsibilities.
* To be responsible for ensuring that all quality issues, and audit non-conformances are dealt with efficiently and promptly. * Ensuring that appropriate NCR/CAPA investigations are carried out in conjunction with manufacturing , and root cause analysis within the manufacturing department arising from recurring non-conformances, audit non-conformances, and other investigations using problem solving tools to identify root cause and implement effective corrections / corrective actions* Review non-conformance and other manufacturing metrics to identify CAPA opportunities* Analyse and review process capability data and other quality metrics in order to propose specification or process changes to manufacturing processes * To contribute to the development of policies, procedures, specifications and protocols within the department.* Responsible for ensuring SOP management within the department.* Determine need for validation of new or changes to, equipment or processes designated manufacturing department* Work with Engineering on validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectiveness* Responsible for the documentation and process management in validation- IQ, OQ, PQ close-out review, justification, and approval.* Responsible for ensuring validation of process/equipment is up to date.* Facilitate with the Change management process supporting manufacturing * Use risk management tools (PFMEA) to evaluate impact of change.* Ensure product verification and process validation requirements are reviewed and defined appropriately.* Participate in Process Improvement projects to support achievement of business metrics (OEE, Past Due, Scrap and other cost savings). * Provide GMP training to staff in the area.* Carry out spot check audits/ gemba walks in manufacturing to be 'audit ready
Essential: * A level or equivalent* Working knowledge of FDA part 820, ISO 13485* Experience of working within QA Engineering or manufacturing QA position in a manufacturing environment within the Medical Device Industry/ or highly regulatory industry* Strong communication skills both written and verbal.* Good understanding for Quality principles / Quality systems.* Experience of non-conforming product and corrective action processes. * The ability to problem solve. * Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgement, decision making and ambition.* Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.* Leadership Skills: Proven ability to influence others and lead significant change.* Able to work with minimum supervision and as part of a team.* Strong communication skillsDesirable:* Degree or equivalent in Biological sciences or similar * Quality Assurance/ manufacturing engineering background* Currently working in a similar role.
If interested please send an updated CV or call 0161 868 2236 for more information
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.