Siemens Quality Engineer 3\Designated Complaint Handling Unit in Tarrytown, New York
Quality Engineer 3\Designated Complaint Handling Unit
Locations:Tarrytown, New York
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 211073
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
The Quality Engineer, Designated Complaint Handling Unit (DCU) will be responsible for the integrity of CAI complaint files and the complaint handling process, and will contribute to measurable improvements in complaint handling, product quality, and the customer experience. The DCU is responsible for all safety complaints, and confirmed product complaints
This role will work closely with a cross-functional team, including - R&D, Product Portfolio Management, Headquarter Support, Manufacturing, and Commercial Product Quality.
• Serve as a Subject Matter Expert for the complaint handling process.
• Provide complaint handling and quality engineering expertise and consultation to significant / complex projects.
• Lead complaint review board forums, assign investigations to cross functional team members as necessary and monitor completion of tasks
• Escalate incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner
• Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions)
•.Ensure prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed
•.Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure
• Participate and support internal, external audits and inspections
• Perform confirmed complaint trending
• Ensure Post Market Surveillance activities are completed
• Provideinput on local DCU procedures and process improvements
• Minimum BA/BS degree in science or other technical field
• Strong technical knowledge of CAI products
• Direct experience handling complaints in the medical device industry
• Experience participating in internal and external inspections (e.g., FDA, LRQA)
• Strong organizational and time management skills
• Strong communication skills (written, oral, and listening)
• Knowledge on CAPA, complaint investigation, and field action processes
• Ability to influence without authority
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations
• Certified Quality Engineer or Certified Reliability Engineer (ASQ or equivalent) and/or
• Clinical background and/or field experience desirable
OTHER/SKILLS AND ABILITIES
• Demonstrated knowledge and application of QSR and international standards
• Ability to influence without authority
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/pay-transp_formattedESQA508c.pdf .