Siemens Senior Quality Systems Manager in Hoffman Estates, Illinois

Senior Quality Systems Manager

Locations:Hoffman Estates, Illinois

Job Family: Quality Management

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Job Description

Division: Siemens Healthineers

Business Unit: Diagnostic Imaging

Requisition Number: 211441

Primary Location: United States-Illinois-Hoffman Estates

Assignment Category: Full-time regular

Experience Level: Senior level

Education Required Level: Bachelor's Degree

Travel Required: 25%

Division Description:

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthcare

Job Description:

The Senior Quality Systems Manager role provides the opportunity to enhance the Quality Management System at Siemens Healthineers Molecular Imaging business line and improve product quality through a robust CAPA and internal audit program. The Senior Quality Systems Manager role would report directly to the VP of QA/RA/EHS for Siemens Molecular Imaging and be responsible for sites in IL and TN.

This position can be located in Hoffman Estates, IL or Knoxville, TN.

The primary job responsibility of the role is to act as the process manager for the CAPA system and the internal audit program. This hands-on role would include performing internal auditing of the Quality Management System in order to ensure compliance to company policies and procedures, as well as, external standards and regulations, including 21 CFR Parts 820, 803, 806, and 1000, ISO 13485, Medical Device Directives (MDD), Canadian Medical Device Regulations, and other applicable standards and regulations.

The responsibilities within the role allow for great visibility, growth, and development from a knowledge and career standpoint:

· Process owner for the Internal Audit program and procedures. Working on enhancing the efficiency and effectivity of the Internal Audit program.

· Process owner for the CAPA system and the CAPA Board meetings held with MI management.

· Leading continuous improvement of Siemens Molecular Imaging Quality Management System through the implementation of robust Internal Audit and CAPA programs.

· Scheduling, planning, and conducting of internal audits at Molecular Imaging sites in Illinois and Tennessee.

· Communicating audit results through closing meetings, Management Review updates, and audit reports.

· Actively managing CAPAs that result from Internal Audits. Providing feedback and guidance to CAPA Owners on corrective and preventive actions.

· Tracking implementation of corrective actions and performing effectiveness verification activities related to audit findings.

· Supporting external audits including interfacing with regulatory agencies such as FDA, ANVISA, TUV, and BSI.

· Staying informed of new and upcoming regulations and industry trends and gathering industry intelligence through reviews of publications, regulatory conferences, and FDA 483s and Warning Letters issued. Properly adjusting the compliance activities at Siemens Molecular Imaging.

· Supporting CAPAs related to external audit findings.

· Conducting site planning and training in preparation of notified body audits and FDA inspections.

· Performing and presenting trending related to the CAPA and internal audit processes.

Qualifications:

· Must be familiar with all elements of a Quality Management System, in particular the Corrective and Preventive Action sub-systems.

· Must be knowledgeable in FDA’s QSRs, ISO requirements, MDD, and CAMDCAS requirements.

· Must have experience with CAPAs as an owner and/or approver.

· Must be reliable and capable of working with minimal supervision to manage audit planning, execution, and follow-up activities.

· Must be able to manage controversial issues that may arise from internal audits through constructive communication with cross-functional teams.

· FDA and Notified Body audit exposure is preferred.

· Must be highly compliance oriented to firmly adhere to the principles of the regulations and standards.

Education/Experience:

· A Bachelor's Degree in a technical discipline such as Electrical Engineering, Mechanical Engineering, Nuclear Medicine or a clinical discipline

· Medical Devices regulations knowledge and experience required

· Internal Auditor Certification preferred

· Travel Required: About 25%

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Equal Employment Opportunity Statement

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .