Fellow Quality Systems Engineer

Boston Scientific • Arden Hills, MN

4h

About The Position

Lead the PAAC sub-process development and maintenance of process metrics and/or methods, as required, for performance, continous improvement, and monitoring of the Process Acceptance and Control processes. Lead continuous improvement through the Quality System Steward and Community of Practice model against strategic roadmap plans of activities. Lead the implementation of training, development of technical tools and drive continuous improvement and efficiency 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. Lead or oversee quality projects of major magnitude and scope. Provide input and oversight to overall quality project portfolio and project priorities. Facilitate external audits through leadership in audit front rooms, 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 10 years of experience in relevant field(s) related to medical device quality systems and/or production and process control or equivalent.
• Understanding of medical device regulations and standards applicable to the BSC Global Quality System and Process Validation and Production Control (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Excellent interpersonal skills, including strong presentation skills
• Demonstrated inclusive leadership skills
• Strong analytical skills

Nice To Haves

• Advanced degree preferred
• 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.)

Responsibilities

• Lead the PAAC sub-process development and maintenance of process metrics and/or methods, as required, for performance, continous improvement, and monitoring of the Process Acceptance and Control processes.
• Lead continuous improvement through the Quality System Steward and Community of Practice model against strategic roadmap plans of activities.
• Lead the implementation of training, development of technical tools and drive continuous improvement and efficiency 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.
• Lead or oversee quality projects of major magnitude and scope.
• Provide input and oversight to overall quality project portfolio and project priorities.
• Facilitate external audits through leadership in audit front rooms, 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

What This Job Offers

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