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 confirmed product complaints and the investigation and closure of safety complaints.
This role will work closely with a cross-functional team, including - R&D, Product Portfolio Management, Headquarters Support Center, Manufacturing, Supplier Quality, and Commercial Product Quality.
Atellica experience is preferred. Product lines supported include Atellica Solution, Automation, and Hematology.
- 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 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
Required Knowledge/Skills, Education, and Experience
- Minimum BA/BS degree in a scientific field (Medical Technology or Engineering preferred) or other technical field
- 5-8 years successful experience in medical device or related field. Advanced degree may be substituted for experience.
- Technical knowledge of laboratory diagnostics products.
- Direct experience handling complaints in the medical device industry.
- Strong communication skills (written, verbal, listening).
- Experience participating in internal and external inspections (e.g., FDA, TUV).
- Ability to lead without authority.
- Strong organizational and time management skills
- Knowledge of complaint investigations, CAPA, and field action processes
• Certified Quality Engineer or Certified Reliability Engineer (ASQ or equivalent) and/or
• Clinical background and/or field experience desirable
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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