Business Unit: Diagnostics
Requisition Number: 242588
Primary Location: United States-New York-Tarrytown
Other Locations: United States-New Jersey-Flanders, United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
This position can be located inTarrytown,NY,Newark,DE, or Flanders,NJ.
The Quality Engineer, Designated Complaint Handling Unit (DCU) will be responsible for the integrity of Laboratory Diagnostics (LD) 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
• Provide input on local DCU procedures and process improvements
• Minimum BA/BS degree in science (Medical Technology preferred) or other technical field
• Strong technical knowledge of diagnostic 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
Job Family Responsibilities:
Analyzes complex production and quality trend data to identify and solve problems. Devises sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data. Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Completes and maintains quality inspection programs for incoming, process, and final approval material and product inspections. Conducts complex audits and/or surveys to determine acceptability of quality controls.
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 a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.Typically 5-8 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.
Direction of Others:
Provides general guidance or train support and/or professional staff.
Key Working Relationships:
Primarily intra organizational contacts and external contacts.
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.