Principal Quality Systems Engineer

Boston Scientific • Arden Hills, MN

3h

About The Position

Support the sub-process stewards in development and maintenance of process metrics and/or methods, as required, for performance, continous improvement, and monitoring for the Process Acceptance and Control processes. Support continuous improvement through the Quality System Steward and Community of Practice model against strategic roadmap plans of activities. Implement training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture. Review and assess changes to standards and regulations applicabe the Production and Process Control processes for potential impact to BSC and initiate projects, as needed, to ensure continued compliance. Support or oversee quality projects of major magnitude and scope. Provide input and oversight to overall quality project portfolio and project priorities. Support external audit front rooms and back rooms, training for SME's, creation of storyboard material and site level support for global procedures. Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal. Act as a CAPA owner for corrective actions necessary to improve the global processes as appliable within the global processes

Requirements

• Minimum of a Bachelor's degree
• Minimum of 7 years experience in relevant field(s) related to medical device quality systems and/or production and process control or equivalent
• Understanding of regulations and standards applicable to the BSC Global Quality System and Process Validation and Production Control (ISO 13485, 21 CFR 820, EU MDR, etc.)
• Understanding of specific regulations and standards applicable to BSC Global Quality System and Process Validation and Production Control (ISO 14971, ISO 11607, 21 CFR 210/211, etc.)
• Experience with enterprise control systems (e.g. Siemens' Manufacturing Execution System, Product Data Management-Windchill, etc.)
• Excellent interpersonal skills, including strong presentation skills
• Demonstrated inclusive leadership skills
• Strong analytical skills

Responsibilities

• Support the sub-process stewards in development and maintenance of process metrics and/or methods
• Support continuous improvement through the Quality System Steward and Community of Practice model
• Implement training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture
• Review and assess changes to standards and regulations applicabe the Production and Process Control processes
• Support or oversee quality projects of major magnitude and scope
• Provide input and oversight to overall quality project portfolio and project priorities
• Support external audit front rooms and back rooms, training for SME's, creation of storyboard material and site level support for global procedures
• Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal
• Act as a CAPA owner for corrective actions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees