Senior Quality Engineer, EU MDR Supplier Workstream Project Team
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Quality Engineer, EU MDR Supplier Workstream Project Team located in Cork or Limerick, Ireland
Who we want:
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.
What you will do:
EU MDR is a new EU regulation which requires all Medical Devices to comply as per the required timelines. Supplier Quality Engineer role lies within the Supplier Workstream to support implementation activities Divisionally. The initial contract is for 18 months.
The following activities are responsibilities within the role:
Remotely execute Supplier Technical Gap Analysis
Front facing with Suppliers to close gaps, using PPAP
Lead key activity; Single Point of Contact to Suppliers, dedicated representative for topics, supplier remediation.
Report to the Supplier Quality Lead
Liaise with Sourcing, and Manufacturing partners
Support all activities required by Divisions to support the execution of EU MDR to meet deadlines
What you need:
Bachelor’s Degree in Science, Engineering or related field
Minimum 5 years’ experience - ideally in Supply and Supplier Quality Function
Quality, engineering, compliance or working in a regulated environment.
Previous experience in medical device, pharmaceutical or automotive industry essential
Experience working onsite developing suppliers preferred.
Experience conducting supplier audits and internal audits preferred.
Quality systems experience; ISO13485, EU MDR & ISO9001 experience preferred.
Demonstrated process knowledge in assigned commodity (i.e. plastics, metals, electronics, PCBAs, etc.) is desired
Work From Home: Occasional
Travel Percentage: 20%
Work From Home: Not available
Travel Percentage: Up to 25%