Act as a member of the Boston Scientific Cork facility quality team. Provide expert QA project support in executing improvements in manufacturing quality processes and systems, ensuring the sites's overall quality and operational objectives are achieved.
Key Responsibilities :
Be the quality lead on value stream and quality process improvement projects.
Drive and implement plant wide quality improvements
Maintain the Cork Quality LBP / VIP process (monthly metrics performance etc).
Lead and support strategic quality projects (e.g. Quality policy, Operational excellence)
Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes (PFMEA, Risk reduction, process change analysis).
Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
Approval of change requests for product, process and quality system changes.
Keep stakeholders informed of project activity status.
Transfer and implement product and processes improvements from other Boston Scientific manufacturing facilities
Educational Requirements :
Minimum of a Bachelor of Science Degree in Engineering / Technology.
3 / 4 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
Experience within a Med Device / Pharma environment i.e. FDA ISO 9000 necessary.
Demonstrate strong leadership skills and promote quality at source
Develop plans and execute on time to these plans
Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
Experience / training in problem solving and process improvement methodologies (Engineering Essentials TM).
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.