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 Quality Engineer.
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, ADVIA Centaur and IMMULITE.
This is a
role well suited to an ambitious professional, looking for the next step in
their career. As a Quality Engineer, you will be responsible for:
- You will serve as a subject matter expert for the complaint handling process.
- You will provide complaint handling and quality engineering expertise and consultation to significant/complex projects.
- You will lead complaint review board forums, assign investigations to cross functional team members as necessary and monitor completion of tasks
- You will participate and support internal, external audits and inspections
- You will perform confirmed complaint trending
- You will 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
- 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
Required skills to have for the success of this role
- Minimum BA/BS degree in a scientific field (Medical Technology or Engineering preferred) or another technical field
- 5-8 years successful experience in medical device or related field. Advanced degree may be substituted for experience.
- Certified Quality Engineer or Certified Reliability Engineer (ASQ or equivalent) and/or clinical background and/or field experience desirable
- Willing to travel 10%
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:
1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR
2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.
(Note: Accommodations may be requested for certain medical or religious reasons)
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.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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