Senior Manager, Process Engineering
Siemens Healthineers · Baden
Description du poste
About the role
Varian Medical Systems is seeking a Senior Manager to lead global manufacturing process governance. You will ensure compliant, high‑quality product delivery through standardized, controlled processes across multiple sites worldwide.
Key responsibilities
- Own global manufacturing quality system documentation and act as process owner for Production Process Controls (PPC), Resource Management (RMT) and related procedures.
- Represent Varian in internal and external audits (ISO 13485, MDSAP) and ensure consistent application across all sites.
- Establish and govern document lifecycle management, including creation, revision, approval and periodic review.
- Drive global standardization of processes, resolve site‑level variation and align to defined requirements.
- Lead end‑to‑end engineering change management execution, ensuring changes are controlled, timely, auditable and effective.
- Manage a multi‑functional team covering process engineering, change management, program management and drafting.
- Define and monitor KPIs for change‑management performance, including cycle time and implementation effectiveness.
- Prepare and coach manufacturing engineering teams for audits, readiness reviews and gap closure.
- Collaborate with Manufacturing, Engineering, Quality and Supply Chain to implement systemic improvements.
- Identify and resolve systemic issues in process execution, documentation quality and change‑management effectiveness.
Required profile
- Deep understanding of manufacturing quality systems, including PPC, risk management and controlled documentation.
- Extensive experience with engineering change management principles and configuration control.
- Proven ability to lead cross‑functional teams in a global, multi‑site environment.
- Strong audit experience with standards such as ISO 13485 and MDSAP.
- Track record of driving continuous improvement and managing CAPA processes.
Required skills
- Manufacturing quality systems
- Production Process Controls (PPC)
- Engineering change management
- ISO 13485 compliance
- MDSAP audit readiness
- CAPA methodology
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Siemens Healthineers
Baden
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