Job Description

Job Summary/Introduction The role of the Quality Engineer is to provide technical Quality Engineering leadership to the business in order to ensure the highest levels of product quality, process, and systems integrity to the customer. Principal responsibilities: Provides Quality Engineering leadership and project management to all areas of the business Minimizes risk to the customer through risk analysis and risk management throughout the product lifecycle Leads reduction of the cost of quality and non-compliance to the business Ensures adherence to Quality system in order to achieve highest levels of compliance and identifies improvements to the system. Utilizing Process Excellence tools and methodologies, leads activities to lean out processes, improve products, raw materials and reduce customer complaints Leads CAPAs to drive improvement NCMR Investigation and implementation of corrective actions Acts as Quality SME to the business Trains others in Quality systems, tools and objectives Works in partnership with Marketing and R&D to ensure customer Quality needs are met at product design and development phase and throughout product development lifecycle In partnership with Manufacturing, leads reduction of non-conforming product and processes Ability to analyze and identify emerging trends, to highlight preventative measure opportunities Supports and deputises for Quality Manager as required Knowledge: * Product Knowledge * Manufacturing knowledge * Knowledge of diabetes * Working knowledge of regulatory and compliance environment i.e. ISO 13485:2003; 21 CFR Part 820, ISO 14971 and ISO 15197 * FMEA; SRA; DOE * Statistics * Working knowledge of failure investigation Skillset: * Quality Acumen * Project Management skills with ability to prioritise and effectively manage to defined timelines * Meeting Management * Financial Acumen * Data driven decision making * Time Management * Technical Specification Writing * Ability to train others * Proactive approach to issue identification and problem resolution * Verbal communications * Negotiation * Resilient and ability to work under pressure. Qualifications Required: Degree in Engineering, Life Sciences or related discipline or equivalent relevant experience ASQ CQE certification or equivalent Green Belt certified Desirable: * Black Belt certified Employer’s Responsibility for Health, Safety & Environment All managers and supervisors are responsible for the health & safety of those working for them and for the minimisation of the environmental impact of the activities under their control. Responsibilities are defined as: Ensure all their staff are adequately trained in required tasks and such training is documented Perform periodic health, safety & environmental inspections and document these Conduct periodic job observations on their employees and encourage their staff to take part in these observations Conduct group HSE meetings with their staff Encourage their staff to report HSE hazards Support their staff who have specific HSE responsibilities or roles e.g. first aider Ensure accidents and incidents are fully investigated and reported and that preventive and corrective actions are closed out HSE is considered when setting their staff’s individual goals Employee’s Responsibility for Health, Safety & Environment All employees have a duty to ensure their own safety, the safety of their fellow employees and the protection of the environment by ensuring they comply with the requirements of the Health, Safety and Environment Policies and Procedures. They must also comply with the control measures stated in risk assessments and Standard Operating Procedures
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