At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Quality Engineer 3 – DCU (Designated Complaint Handling Unit).
The Quality Engineer, Designated Complaint Handling Unit (DCU) will be responsible for the integrity of 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.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Engineer 3, you will be responsible for:
- 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
This position may suit you best if you are familiar with what is below and would like to do develop your career with Healthineers. Desirable skills/ experience/ certifications include:
- Certified Quality Engineer or Certified Reliability Engineer (ASQ or equivalent) and/or Clinical/ Medical Technologist background and/or field experience
Required skills to have for the success of this role
- Minimum BA/BS degree in science or other technical field
- Strong technical knowledge of Laboratory Diagnostics 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
OTHER/SKILLS AND ABILITIES
- Demonstrated knowledge and application of QSR and international standards
- Ability to influence without authority
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
Job ID: 192842
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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