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Boston Scientific is seeking a Principal Quality Systems Engineer & Records Control Quality Steward to provide leadership and stewardship of the Records Controls process and Community of Practice, and to own the digital systems transformation in the Document Management space.

Requirements

• Minimum of 5 years of Quality Systems experience
• Regulated industry experience
• Understanding of regulations and standards applicable to the BSC Global Quality System and Document & Records Control processes (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Medical device experience
• Document and/or Records Management
• Digital product ownership and/or IT project experience
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Responsibilities

• Quality System Stewardship for assigned area.
• Lead the development and ownership of the strategic roadmap, including digital transformation strategy.
• Lead identified activities through leadership of the Community of Practice.
• Implement training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
• Lead or oversee quality projects of major magnitude and scope.
• Act as a CAPA owner for corrective actions necessary to improve the global processes.

Other

• Minimum of Bachelor’s degree in relevant field
• Strong analytical and communication skills
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution