Siemens Complaint Analyst 4 in Issaquah, Washington
Complaint Analyst 4
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Quality & Technology
Requisition Number: 200709
Assignment Category: Full-time regular
Experience Level: Mid 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 position has responsibility for all aspects of complaint management, specifically assessing complaints for potential safety issues, investigating customer complaints, filing MDRs and Vigilance Reports, working with cross functional teams to determine root cause, and reviewing/closing complaint files.
The candidate must have experience with FDA 21 CFR 820, 803 and ISO13485 post market surveillance requirements and experience in system implementation. They will:
• Ensure compliance with all post market activities including complaint processing and investigations, heath risk evaluations, field corrective actions and CAPAs
• Chair post market surveillance teams to assign investigation leads, track investigation progress and ensure root cause determination.
• Drive product investigations to obtain thorough root cause analyses
• Report post market surveillance metrics on a periodic basis.
• Respond to audit issues, and questions generated internally and externally with regard to customer complaints.
• Assist in maintaining the quality system to ensure that it continuously reflects current regulatory requirements.
• Proactively review the quality system and participate in special projects related to the continuous improvement of the quality system.
• Assist with the coordination of external audits from regulatory authorities
• Stay current with applicable regulations, quality standards/systems for all company products and markets
BA/BS required. Graduate degree preferred. Mandatory 7 plus years experience working in medical device post market surveillance activities, with strong emphasis on medical imaging software. Experience in other Quality System elements a plus. Good working knowledge of FDA and international medical device regulations; Strong project management skills. Effective writing and communication skills. IVD, pharma and biotech need not apply.
Job Family Responsibilities:
Develops and facilitates training on QMSTs. Devises sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data. Conducts economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Develops and provides guidance to multiple operations for QMST. Develops and initiates standards and methods for inspection, testing, and evaluation.
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Knowledge and Experience:
Demonstrates and applies comprehensive knowledge of field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues.Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.
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.
EEO is the Law
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/PayTransparencyNotice_JRFQA508c.pdf .