Quality System Analyst

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Varian Medical Systems is seeking a Quality System Analyst. This role entails elaborating, analyzing, and implementing quality concepts, methods, tools and procedures as part of an effective agile/lean-oriented Quality Management System (QMS) supporting the Quality System Operations team. The role will play a pivotal role in supporting the execution of CAPAs within the enterprise wide QMS by performing independent review of global CAPA records and providing coaching and guidance to CAPA owners to ensure adherence to the quality standards. This role will support Quality System operations team in execution of projects in areas such as document and record control, non-product software validation, CAPA and training systems.

What You will do:

• Perform independent reviews of global CAPA records to ensure compliance with procedures, standards, and proper and complete documentation. 
• Support global CAPA program management with reporting, tracking, training and communications.
• Mentor and coach Issue Review and CAPA owners on essential elements and best practices, emphasizing containment, root cause analysis, and timely corrective/preventive actions, as well as their associated effectiveness checks.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances, as well as opportunities for improvement.
• Support management by providing CAPA metrics, aligning processes with organizational goals, and contributing to ongoing improvement initiatives.
• Creates transparent and open environment for quality culture together with management.
• Drives innovative digital solutions (AI) to improve quality by thinking outside of the box, coaching and fostering the application of creativity methods.
• Coaches team members of agile/lean projects or even leads agile projects e.g. as a SCRUM master.
• Ensures effective cooperation with both internal and external stakeholders as needed.
• Participates as part of the Varian Internal Auditor pool performing internal audits.
• Supports the non-product software validation program as a Compliance Reviewer ensuring validation records are executed and documented per standard procedures.

What You will have:

• Bachelor’s degree in engineering, supply chain management, or another related field.
• Proven experience of 5+ years in supply chain, quality, design or manufacturing operations, with a focus on CAPA processes.
• Strong, practical understanding of aspects related to regulated industries, quality standards, and GMP principles.
• Proven experience in project and change management, process excellence, and business management techniques.
• Demonstrated problem-solving skills and the ability to understand, analyze, and conduct thorough root cause analyses through the use of specialized tools and techniques across a diverse set of processes, including software and hardware-related design issues.
• Ability to conduct risk assessments as they pertain to CAPAs to prioritize and address critical issues.
• Effective communication and collaboration skills and the ability to collaborate seamlessly with various business areas, cross-functional teams, management, and executives at all levels.
• Ability to lead and facilitate CAPA review meetings, training sessions, and process improvement initiatives.
• Proficiency in using quality management tools and software, as well as supply chain management systems.
• Knowledge of statistical techniques and methodologies for data analysis.

What will set You apart:

• Relevant certifications (e.g., Certified Lead Internal Auditor, ASQ Certified Quality Engineer,  Lean/Six Sigma Green Belt, etc.) are a plus.
• Practical experience pertaining to the medical device industry, applicable regulations, and standards (e.g., 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), EU Medical Device Regulation (2017/745), and Canadian Medical Devices Regulation (SOR/98-282), MDSAP, etc.).
• Thorough understanding of software and hardware-related problem-solving and non-conformance management standards and methodologies.
• Practical knowledge and the ability to identify and categorize potential risks based on industry standards (e.g., ISO 14971:2019, etc.).
• Experience in collaborating with cross-functional teams, developing, organizing, and prioritizing key executive leadership and committee activities to facilitate strategic decision-making activities.
• Experience with implementing Artificial Intelligence enhancements to support QMS operations and activities a plus.

#LS-OS1

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Healthineers’ specific businesses, please visit our company page here.

The base pay range for this position is

Min $91,000 - Max $136,500

Base pay offered may vary depending on job-related knowledge, skills, and experience. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.  

This information is provided per the required laws and regulations. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site

As an equal opportunity employer, we welcome applications from individuals with disabilities.

Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees.  These scammers may attempt to collect your confidential personal or financial information.  If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.