The Senior Quality Engineer will be responsible for driving Quality Operational Excellence across all business activities in an Automation company supplying bespoke machines to the world’s most advanced medical device manufacturers. The Senior Quality Engineer will utilize key Quality Management systems tools to maximize business efficiency while embedding a culture of Continuous Improvement through Quality Assurance activities.
This role requires a very strong understanding of the principles of Quality Systems, Quality Assurance and Quality Control activities, QMS Process Optimization and strong analytical skills in gathering data from groups, defining work problems, and working with operational teams to design effective solutions and develop and implement systems.
• Minimum of 6+years' experience in QA/Compliance in a regulated environment.
• A third level Degree in a related Science or Quality Management discipline.
• Internal Audit Accreditation would be preferable.
Key Skills & Attributes
• Strong knowledge of the ISO 9001:2015 Directive
• Proficient in the Use of Problem Solving and CI tools
• Systems and Process thinking
• Enthusiasm for collaboration across Departments
• Excellent communication skills
• Preference for a structured approach to working
• Time management
• Internal and External Customer focused
• Experienced in leading and supporting internal and external Audit programs.
• Attention to detail
LEAN and 6 Sigma would be an advantage.
• Lead and manage the site QMS including Document Control activities, standardization activities, develop systems, reporting of quality trend data, and taking appropriate action.
• Reviewing and approving documentation required at each stage of the project lifecycle – FDS, SOP’s, Project checklists, BOM’s, User Manual pack etc.
• Creation of internal test documentation and ensuring all machines are inspected and tested to meet customer requirements.
• Final review of equipment prior to shipment.
• Lead projects on all quality related issues and ensuring an effective and robust quality system which complies with all relevant regulatory requirements. Participate and lead investigations (NC / CAPA), involving but not limited to collecting, identifying and analysing information, investigating product and quality problems and identify effective corrective actions.
• Ensuring training records are maintained to ensure all employees trained on new or changed procedures.
• To effectively manage and report all Quality Metrics including Production metrics, Non-Conformities, Change controls, SOP’s. Ensuring all actions are assigned and tracked to ensure compliance with critical quality KPI’s.
• Drive the understanding across the company of the cost of quality through Critical To Quality initiatives and Right First Time.
• Develop and implement systems to collect data to identify problems and to identify improvement opportunities.
• Lead internal and support External/regulatory audits, including audit preparation, queries during the audit and follow up of actions to closure
• Interface with other departments to ensure that Quality system requirements are adhered to.
• Establish and manage key metrics in the areas of quality control, project delivery and customer satisfaction.
• Lead the continuous improvement of the QMS including the development and implementation of improved quality reporting measures.