Senior Quality Engineer

Job Summary:In this role, you will report to the Quality Engineering Manager this role is responsible for coordinating the necessary activities for ensuring the timely closure of internal/external quality issues / projects and to coordinate / drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Essential Duties and Responsibilities: Interface with customers to ensure concerns/complaints are communicated and corrective actions are closed in a timely manner. Support new programs with respect to validation, data analysis and system implementation. Act as mentor to the business with respect to the use of Lean / 6 Sigma tools. Support internal audit function in order to monitor compliance / drive improvements. Manage and drive quality projects in support of continuous improvement. Trending and track of quality data to support quality improvements across the business Reacting and ensuring the timely closure of day-to-day quality issues e.g. CAPA / deviations and change controls. Complete batch / sample inspections and documentation in line with batch manufacturing rules and GMP requirements Support incoming inspection and controls as per GMP requirements. Batch paperwork review and final decision to release product for shipment. Facilitate risk assessments as required to ensure continuing compliance, safety and quality of our processes and products. Interface with other departments with respect to sharing of best practices. Monthly reporting of key performance indicators (KPI’s) and coordinating necessary activities to drive improvements or address adverse trends. Management of customer documents into the TGE Quality system i.e. drawings; purchase specification; quality agreements etc. and the training out of relevant personnel. Drafting and approving of quality documentation to meet TGE and Customer requirements i.e. Quality Specification Sheets (QSS), CAPA’s, deviations, defect library, raw material specification etc. Participate in the review of validation protocols and reports to ensure quality compliance. Executing internal and external process and system audits. Co-ordinate activities associated with change management and customer interaction. Interface with other departments on a daily basis. Analysing and reporting of key measures e.g., Ppk’s, Cpk’s, cost of quality, customer complaints, and internal/external quality results. Compliance to all local site company policies, procedures and corporate policies. Perform additional duties at the request of the direct supervisor. Lead and manage a high performing team to deliver the defined business goals and objectives. Act in accordance with the company’s guiding principles and adherence to the corporate Code of Conduct. Identification and development of talent to include performance management and succession planning (in the West Talent Gateway). Coaching / development of reports using development and retention plans as appropriate. Responsible for the identification and development of talent, to include performance management, coaching and mentoring for high performance. Basic Qualifications: Must have a third level qualification in Engineering/Quality/Science. Must have a minimum of 5 years’ experience of working in a high volume manufacturing environment ideally in the medical device / pharmaceutical sector. Must have a thorough understanding of statistics, SPC, and ideally the use of minitab. Must have an in-depth knowledge of validations in a medical device environment. Must have excellent communication skills both oral and written. Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Auditing experience to 21 Part 820 / and EU GMP is considered an advantage. Must be able to prioritize and organise tasks. Preferred Knowledge, Skills and Abilities: Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description Support and contribute to Lean Sigma programs and activities towards delivery of the set target. Able to comply with the company’s safety policy at all times. Able to comply with the company’s quality policy at all times. A background in drug handling would be considered an advantage. A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential. Knowledge of EU GMP is considered a requirement for working in the Medical area. Ideally would have experience of third party and regulatory audits and the preparation of same. Ideally have an understanding of Environmental Management System ISO 14001. Ideally have a working knowledge of Lean / 6 Sigma tools. Green Belt certification in preferred. Travel Requirements: Must be able to travel up to 5% of the time. Physical and Mental Requirements: Must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects. Must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data. Delegation of Duties: When absent from the site duties and responsibilities will be delegated to the following designates: Quality Engineering Manager