Siemens Head of Designated Complaint Unit – Post Market Surveillance Manager in Hoffman Estates, Illinois
Head of Designated Complaint Unit – Post Market Surveillance Manager
Locations:Hoffman Estates, Illinois
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Diagnostic Imaging
Requisition Number: 211505
Primary Location: United States-Illinois-Hoffman Estates
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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
The Head of Designated Complaint Unit (DCU) is a Quality Management role responsible for post-market surveillance activities at Siemens Healthineers Molecular Imaging business line.
This role reports to VP of QA/RA/EHS with primary responsibility for overseeing the complaint handling unit, adverse event reporting including FDA MDR reporting, and management of field corrections and removals from a quality perspective, including FDA 806 recall reporting. This Quality Managerwill have overall responsibility for ensuring the DCU and related processes are compliant, effective, and efficient.
Please note this position can be located in Hoffman Estates, IL or Knoxville, TN.
· Lead the post-market surveillance program at Siemens Molecular Imaging for sites in Hoffman Estates, IL and Knoxville, TN.
· Responsible for management and development of Quality Engineers within the DCU including setting and monitoring department goals and objectives.
· Create enhanced metrics to identify potential product safety issues and opportunities for product quality improvements through risk management activities, trending, and review/approval of complaint files.
· Participate in Siemens Healthineers corporate and global teams and projects, representing Molecular Imaging.
· Participate in risk management activities associated with complaints and field actions
· Lead necessary post-market surveillance related communications with the FDA.
· Present complaint data to executive management at Quality Management Reviews.
· Determine the need for field corrections and removals and contribute to recall reporting decisions based on 21 CFR 806.
· Maintain in-depth knowledge of post-market regulations by participating in industry groups, conferences, and training.
· Key participant in FDA inspections, Notified Body audits, and other external audits.
· Responsible for complying with EU post-market surveillance requirements and supporting Regional Countries with vigilance reporting.
· A Bachelor's Degree in a technical discipline such as Electrical Engineering, Mechanical Engineering, Nuclear Medicine or a clinical discipline
· 7-10 years of experience in an RAQA function
· Experience participating in FDA inspections
· Strong organizational and leadership skills
· Functional management experience
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 .