Quality Systems Manager
Business Unit: Healthineers (HC)
Requisition Number: 239666
Primary Location: United States-Indiana-Mishawaka
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
"Are you ready to join the Northern Indiana One Team....One Siemens Quality Family?"
The qualified candidate will work as a member of the Manufacturing Quality Assurance group at the Mishawaka, IN site. As the new quality manager this individual will use their leadership skills to drive improvements in the site quality management system functions and collaborate with the site Head of Quality in ensuring the site maintains compliance to FDA and ISO Quality Management Systems for medical devices.
This person will manage the site quality system to ensure site compliance to applicable external regulatory standards. The person will manage the site documentation, training function and site CAPA system. The individual will be the Internal Audit Coordinator for a group of Lead auditors who perform internal and supplier audits. This individual will be the CARB Coordinator for the site CAPA investigators. This individual coordinates Finished Product deviations and change notices within the SAP Quality Management system, as well as maintains a materials review board. The individual reviews and makes recommended changes in methods and appropriate departmental / site QMS procedures. The candidate drives process measurement initiatives and process improvements. The individual will participate in troubleshooting and resolving complex problems associated with site quality initiatives. Lastly, this individual will manage a strong team of (four) quality system support individuals.
Required Knowledge/Skills, Education, and Experience
The successful candidate will possess a B.S. in science ( preferred). The candidate will have at least 5-8 years of experience in Quality Assurance, medical devices, management, and successful demonstration of Key Responsibilities. The candidate will have an advanced knowledge of FDA and ISO 13485 Quality Management Systems and have applied them to the workforce. Knowledgeable and use of problem solving techniques is preferred. The person must be a certified lead auditor. This person must have a working knowledge of Microsoft Office products, and experience with SAP is preferred. The successful candidate will have: managerial experience
Possess effective written and verbal communication skills
Strict attention to detail
Driven by impact and is focused on results
Acts as an entrepreneur and embodies a ownership culture
Demonstrates ingenious big-picture thinking, manages ambiguity and makes decisions
Has a winning attitude, fosters a winning spirit
Inspires others, fights to win, takes and manages risks, accepts the occasional failure
Empowers employees to take responsibility for results
Preferred Knowledge/Skills, Education, and Experience
CARB Coordinator ( extensive RCA training)
Internal Audit Coordinator
FDA Audit- Facing Experience
SAP QM experience