Quality Team Lead

Quality Team Lead

excel recruitment | Cork, IE

Posted 3 days ago

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Description

Location: CorkReq Number: 509959  Contract Type: Permanent At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion. Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.Purpose Statement Key member of the Boston Scientific Cork facility quality team. To provide expert QA leadership to the Embold Operations and process improvement project teams, in ensuring operational and project goals and objectives are achieved for the plant. Embold is a recently launched Embolization coil and is a flagship product for the Peripheral Interventional Oncology division and BSC Cork manufacturing plant. There are currently approx. 100 Product Builders building the product and continued growth will see this number rise significantly and to accommodate this the construction of new Cleanroom space will be required. There will be dedicated teams focused on driving costs improvement projects which will result in one of the largest VIP saving in the BSC manufacturing network. The Embold Quality Team Lead role will be a high profile role with opportunities to for the development of leadership, project management, planning & prioritisation and collaborative skills. It is a role that will have visibility at high levels of the organisation as there will opportunities to present to senior leadership. Responsibilities:  Key member of the Embold Leadership Core team with Operations and Engineering, which fosters and sustains an environment with strong teamwork where honesty and trust prevails. Lead & develop a team of Quality Engineers and Quality Technicians. Planning & prioritising core team activities. Drive a preventive quality culture in the Embold area to ensure there is buy in to continuously improve the quality performance and ensuring issues are identified proactively (e.g. Risk Reduction, Error proofing etc.). Drive and support the implementation of process improvements to reduce variation and ensure predictable processes across all product lines (e.g. Yield improvements, Product Performance Improvement, Cost Reduction initiatives, Process Automation activities). Provide effective and responsive QA support to Embold production area to ensure objectives of quality, service and cost are met. Key decision maker to ensure the quality issues are assessed and product dispositions are made appropriately and in a timely manner. Review of Non-conformance trends and identification of appropriate corrective actions when required. Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Process Characterisation, FMEA’s). Drive and implement plant wide functional quality performance improvements. Support the integration of new Embold product iterations into manufacturing area. Ensure regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and DEKRA). Provide functional expertise to other support functions on quality related issues (e.g. change management, statistical techniques, sampling principles). Lead the assessment and approval of change requests for product, process and quality system changes. Analysis of complaint trends and lead investigation into potential manufacturing related complaints. Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval. Support the site internal quality audit program. Education/Experience:  Requires a minimum level 8 qualification in a relevant Engineering / Science degree. Excellent interpersonal and communication skills. Ability to work as part of a team and meet targets/goals efficiently. Excellent analytical and problem-solving skills. Demonstrated decision making skills. Minimum of 4+ years’ experience within a manufacturing environment. People management experience is advantageous. Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment. About us Purpose and Passion – Comprehensive Benefits – Life-Work Integration – Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work. As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen. Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran