Global Internal Audit & Compliance Director

Boston Scientific; Arden Hills (MN); Ibrido; USD 162.000 - 309.000; Tempo pieno

Descrizione del lavoro

Boston Scientific seeks a Global Regulatory Compliance Director, Internal Audit to lead the GRC internal audit program across the global Quality Systems group. You will shape the multi-year strategy, govern internal audits, and drive continuous improvement with site, divisional, regional, and corporate leadership.

You’ll partner with Quality leaders to ensure risk-based, data-driven audits and strong compliance with ISO 13485, 21 CFR 820, and EU MDR.

Competenze

• Bachelor's degree in a relevant field.
• 10+ years of Medical Device Quality Systems experience, including leading internal/external audits.
• Strong understanding of ISO 13485, 21 CFR 820, EU MDR, and related standards.
• Demonstrated inclusive leadership with global teams and senior stakeholders.
• Willingness to travel up to 25% domestically and internationally.

Mansioni

• Lead, coach, and develop a global team of quality system audit leaders and auditors.
• Define and deploy the multi-year internal audit strategy in partnership with Quality leaders across the network.
• Oversee identification, documentation, and remediation of significant quality system nonconformances.
• Serve as global process steward for the Internal Audit process and governance.
• Own the internal audit strategic process roadmap and lead communities of practice.
• Sponsor and drive CAPA ownership for corrective actions and improvements.

Conoscenze

Bachelor's degree

10+ years QA/QA audit leadership

Regulatory knowledge (ISO 13485, 21CFR

Inclusive leadership

Travel up to 25%

Formazione

Bachelor's degree in a relevant field

Descrizione del lavoro

Boston Scientific seeks a Global Regulatory Compliance Director, Internal Audit to lead the GRC internal audit program across the global Quality Systems group. You will shape the multi-year strategy, govern internal audits, and drive continuous improvement with site, divisional, regional, and corporate leadership.

You’ll partner with Quality leaders to ensure risk-based, data-driven audits and strong compliance with ISO 13485, 21 CFR 820, and EU MDR.