Siemens Senior Manager Quality Systems in Hoffman Estates, Illinois

Senior Manager Quality Systems

Locations:Hoffman Estates, Illinois

Job Family: Quality Management

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Job Description

Division: Siemens Healthineers

Business Unit: Information Technology

Requisition Number: 230492

Primary Location: United States-Illinois-Hoffman Estates

Assignment Category: Full-time regular

Experience Level: Senior level

Education Required Level: Bachelor's Degree

Travel Required: 35%

Division Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

Job Description:

Siemens Healthineers is currently looking for an experienced and talented Senior Manager of Quality . The Senior Manager will be responsible for the development and implementation of Medical Device Quality systems. He/she will report directly to the VP of QA/RA/EHS for Siemens Molecular Imaging and be responsible for sites in IL and TN.

The primary job responsibility of the role is to develop and sustain a robust quality management system to ensure compliance to 21 CFR Parts 820, 803, 806, and 1000, ISO 13485, EU Medical Device Regulations(MDR), MDSAP, and other applicable standards and regulations. In addition, the role will be responsible for developing and maintaining the Document Control and Training program for the business.

Tasks include:

· Managing the Internal Audit program, CAPA program, Documentation and Training program

· Manage team consisting of Quality Engineers & specialists

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

· Stay informed of new and upcoming regulations and industry trends and drive continuous improvements to the Quality System

· Interface with senior management of the business to drive quality improvements

· Develop training and competence management processes that demonstrate compliance to regulations

· Manage the front room and backroom processes

Qualifications:

· Must be familiar with all elements of a Medical Device Quality Management System

· Must be knowledgeable in FDA’s QSRs, ISO requirements, MDD/MDR, and MDSAP requirements.

· Must have experience with Front room and back room management

· Must have experience in Document control & training related processes in a regulated environment

Education:

· Engineering/Technical Degree strongly preferred

· 10+ years of direct industry experience

Travel Required: 25-35%

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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 .