Fellow Quality Systems Engineer at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Mar, 26

Salary

0.0

Posted On

17 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Process Improvement, Medical Device Regulations, Project Management, Training Development, Analytical Skills, Interpersonal Skills, Leadership Skills, Enterprise Control Systems, CAPA Management, Compliance, Audit Facilitation, Technical Tools Development, Process Metrics, Continuous Improvement, Performance Monitoring

Industry

Medical Equipment Manufacturing

Description

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 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.). 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.) Excellent interpersonal skills, including strong presentation skills Demonstrated inclusive leadership skills Strong analytical skills

Responsibilities

Lead the development and maintenance of process metrics for the Process Acceptance and Control processes, focusing on continuous improvement. Oversee quality projects and facilitate external audits while ensuring compliance with medical device regulations.