Quality Engineer 7

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Supports the quality culture of an Engineering unit by process and method competence.
The Quality Engineer, Commercial Product Quality (CPQ) will be responsible for the integrity of Laboratory Solutions (LS) complaint files and the complaint handling process, will contribute to measurable improvements in complaint handling, product quality, and perform post market regulatory tasks. The CPQ is responsible for the handling, investigation, closure of Laboratory Solutions customer complaints, medical device assessment and reporting.
This role will work closely with a cross-functional team, including - R&D, Product Portfolio Management, Regional Customer Support Unit, Service Operations Support, Manufacturing, and Supplier Quality.
Product lines supported: All Laboratory Diagnostics product lines.

• 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. Working with members of other teams to review, assess, and close potentially reportable events complaints, including MDR reporting.
• Ensure Post Market Surveillance activities are completed.
• Evaluating complaints and oversee decisions on medical device reporting, and documentation of those decisions. Perform control point checks on Medical Device Reports (MDR) coming due to ensure no late MDR/MIRs.
• Filing MDRs when needed and communicate (as appropriate) to the Authorized Representative or Regional Unit.
• Providing support in all areas associated with MDR/MDVR/MDPR reporting and trending and metrics.
• Supporting and participating in internal and external audits.
• Interacting with regulatory authorities around the world.
• Updating procedures related to complaint handling, post market vigilance and surveillance activities.
• Participating and determining proper corrective and preventive actions for process related concerns.

Required Knowledge/Skills, Education, and Experience

• 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.
• Technical knowledge of Laboratory Diagnostics products such as, Atellica Solutions, Chemistry, and immunoassays (systems and reagents).
• Experience handling complaints and/or complaint investigations
• Knowledge of global vigilance reporting requirements, including the United States and Europe
• Knowledge of FDA, EU, and global knowledge of post market surveillance activities
• Strong communication skills (written, verbal, listening).
• Experience participating in internal and external inspections (e.g., FDA, TUV).
• Ability to influence, drive results, and collaborate on complex projects.
• Strong organizational and time management skills.
• Proficiency MS Office software like Word, PowerPoint, Excel and Outlook

CERTIFICATIONS/LICENSES/REGISTRATIONS:
• Certified Quality Engineer or Certified Reliability Engineer (ASQ or equivalent) and/or
• Clinical background, Software validation/Verification, and/or field experience desirable

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A Successful candidate must be able to work with controlled technology in accordance with US export control law when required. It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

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Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

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The base pay range for this position is

Min $95,300 - Max $143,000

Base pay offered may vary depending on job-related knowledge, skills, and experience. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.  

This information is provided per the required laws and regulations. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site

As an equal opportunity employer, we welcome applications from individuals with disabilities.

Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

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