Senior Quality Engineer

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Supports the quality culture of an Engineering unit by process and method competence.

Join our team now at Siemens Healthineers as a Senior Quality Engineer.

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:

• 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

Who we are: We are a team of more than 72,000 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.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$89,220 - $122,672

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement: Siemens Healthineers 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, mari