Quality Engineer II
Corindus, Inc.

Job Info

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Our Global Team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our Culture : We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

We are currently looking for an ambitious Quality Engineer II to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.

As a Quality Engineer II you will be responsible :

• Collaborate with R&D to develop and implement incoming and in-process inspection processes and procedures to support New Product Development (NPD) activities. This includes the development and operation of Coordinate Measuring Machines (CMM), optical measurement systems, and other metrological methods.
• Conduct incoming inspections of mechanical, electrical, and single-use consumable components for R&D prototype and verification/validation builds.
• Oversee the Calibration program as the Calibration Coordinator, including database/record maintenance, managing calibration cycles, coordinating with external vendors, and reporting program metrics to Quality leadership.
• Oversee the Preventive Maintenance (PM) program as the PM Coordinator, including the maintenance of the PM data base/assisting in the implementation of new PM tracking system, monitoring the schedule of PMs, handling of PM records and reporting program metrics to Quality leadership.
• Participate in the supplier management and qualification process including the maintenance of the Approved Supplier List (ASL) for both sustaining and NPD activities.
• Sustain Manufacturing operation by completing in-process inspection, including documentation in DHRs and collection/review of environmental monitoring data, as appropriate.
• Support ongoing Quality Management System (QMS) activities, including handling Non-Conforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs), and Complaint investigations. Additionally, compile and report related metrics to Quality leadership.
• Provide support to Documentation Control by reviewing and implementing Engineering Change Orders (ECOs), assigning and managing employee training plans and managing of the periodic review procedures and compliance standards.
• Any other responsibilities deemed necessary.

Required skills to have for the success of this role:

• Bachelor's degree in a scientific, technical or related field required.
• Minimum of 3-5 years of relevant quality experience required.
• Medical Device manufacturing experience preferred.
• Attention to detail, organizational and time management skills.
• Ability to work independently and as part of a cross-functional team in a fast-paced environment.
• Experience with managing/coordinating with Calibration/Maintenance vendors.
• Experience with the development of metrological methods for inspection (CMM, Optical Comparators and Measurement systems).
• Experience in procedure writing (SOPs/ Work Instructions).
• Familiarity with ANSI/ASTM/MIL standards.
• Experience using precision hand tools, measuring geometric tolerances, and reading a basic wiring and engineering drawings.
• Experience with ERP systems (SAP) preferred.
• Some experience in PCBA inspection preferred.
• Knowledgeable in Microsoft office products.
• Ability to analyze data using Excel and/or Minitab.

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.

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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.

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Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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