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Senior Quality Engineer at Siemens

Senior Quality Engineer

Siemens Elkhart/Indiana, IN Full-Time
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. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Senior Quality Engineer. This position will assist in the maintenance and support of the Quality Management System activities for design and manufacture of in-vitro diagnostic reagent components in the Protein Development Services group at the Siemens Healthcare Diagnostics, Inc. Elkhart Site. 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. Check our Careers Site at [ Link removed ] This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Quality Engineer, you will be responsible for: Managing Quality projects for the group while providing subject matter expertise of related of QMS processes. Conducting process reviews and process FMEAs. Supporting the CAPA process at site. Participating in root cause investigations. Performing routine internal audits and supplier audits as required. Assisting in preparation for FDA inspections and registrar audits. Serving as SAP QM Administrator and Quality Notification coordinator for group. Assisting with assessment and disposition of Nonconformance. Managing change control projects including related risk assessments. Reviewing and approving equipment enrollment and discrepant equipment reports. Demonstrating strong value orientation with the ability to lead teams and positively influence outcomes. Solving problems of moderate complexity. Effectively communicating with internal and external customers. Exhibiting lean leadership skills to support a continuous improvement environment. Required skills, education, and experience that will enable you to succeed in this role: BS in Life Science – Biochemistry, Biology, or Chemistry disciplines preferred. Requires technical expertise in one or more major QMS areas: validation, nonconformance, CAPA, change management, risk assessment, test method transfer, design transfer Requires technical expertise in the applicability of 21 CFR 820 regulations and ISO 13485:2016 standard requirements. Preferred skills, education, and experience: In Vitro Diagnostic/Immunoassay experience SAP Quality Management Lead Auditor Design Transfer 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. Why you’ll love working for Siemens Healthineers Be part of exciting and innovative projects that help solve some of the world’s most significant health problems. Engaging, challenging, and fast evolving, cutting edge technological environment. Opportunities to advance your career. Competitive total rewards package. Contribute to our social responsibility initiatives focused on access to education and technology, and sustainability, making a positive impact on communities. Participate in our celebrations and social events. Opportunities to contribute your innovative ideas and get paid for them! Employee perks and discounts. We are globally recognized as an Employer of Choice, but don’t just take our word for it. Here are some of our most recent awards and recognition: Great Place to Work Certified 2021 Best Places to Work for LGBTQ Equality Best for Vets Employers by Military Times Glassdoor Employer Rating: 4.0 Review our Benefits Summary: Explore the Siemens Benefits QuickStart [ Link removed ] website to learn about our competitive Benefits plans which we proudly offer to our regular full-time employees. The QuickStart website can be accessed by clicking the link above or by copying and pasting it into your web browser’s address bar and selecting “Thinking of Joining Siemens” to the left of the page. 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. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site. If you want to join us in transforming the way healthcare is delivered, visit our career site at [ Link removed ] If you wish to find out more about the specific before applying, please visit: [ Link removed ] 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 Full / Part time: Full-time 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. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. Pay Transparency Non-Discrimination Provision Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here. California Privacy Notice California residents have the right to receive additional notices about their personal information. To learn more, click here.

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