Staff Quality Engineer, Internal Audits

About the role

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Staff Quality Engineer, Internal Audits, is responsible for providing advanced technical leadership in the planning, execution, reporting, and improvement of regulated Quality Assurance activities for internal and external audits within the Cardiac Assist business. The position independently leads all, including complex, risk-based audits; evaluates systemic compliance and remediation effectiveness; coaches other auditors; and influences cross-functional quality-system improvements. The role assesses compliance with applicable FDA QMSR and related requirements, ISO standards, EU MDR requirements, MDSAP, other worldwide health-authority regulations and guidance, site procedures, protocols, and industry standards.

Responsibilities

• Independently plans, leads, conducts, documents, and follows up on complex, risk-based internal audits and re-audits across Cardiac Assist functions, sites, and quality-system processes in accordance with the approved audit procedure and schedule.
• Serves as lead auditor for high-complexity or cross-functional audits; defines audit scope, criteria, sampling strategy, agenda, resources, and reporting approach based on product, process, compliance, and business risk.
• Prepares and issues timely, clear, evidence-based audit reports, including well-supported observations and nonconformities, classification or significance assessment as defined by site procedures, and an overall assessment of quality-system compliance.
• Ensures audit observations and nonconformities are appropriately contained, investigated, documented, corrected, and closed on time; evaluates root-cause adequacy, corrective