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.

Join our team as a Post-Market Quality Engineer.

Role Summary 

The Post Market Quality Engineer III is a senior technical specialist responsible for managing end-to-end post-market surveillance and compliance activities for assigned products. This role is an ideal opportunity for an ambitious and driven professional. As a Post Market Quality Analyst III, you will play a pivotal role in maintaining the quality and safety of our products within the Point of Care portfolio.

Responsibility

The responsibilities of the role include, but are not limited to:

• Owns and manages complex and critical complaints to ensure they are appropriately scoped, prioritized, and executed.

• Executes and supports technical investigations using logs, retains testing, manufacturing data, and historical field performance to drive fact-based conclusions.

• Ensures robust, well-documented justifications for reportable and non-reportable decisions.

• Fulfills global vigilance reporting requirements by drafting, reviewing, and submitting reportable incidents (e.g., MDRs, MIRs, and related submissions), including regulatory authority inquiries, and follow-ups.

• Manages and supports Field Action (FSCA/Recall) evaluation and execution.

• Tracks and reports on KPIs, trends, and post-market performance metrics.

• Acts as a subject-matter expert for audits and cross-functional teams.

• Supports and drives continuous improvement initiatives to improve the efficiency and effectiveness of post-market processes.

• Performs other duties as assigned.

Qualifications

Education and Experience:

• A bachelor’s degree in a scientific or related technical field is required.

• 3 to 5 years of experience and a proven track record of high performance and competency of Post-Market and Medical Device Regulations

• Hands-on experience handling complaints in the Medical Device industry, specifically in Point of Care devices, and familiarity with medical device regulations.

• Clinical background or field experience in a Point of Care or related setting is highly desired.

• Background in quality assurance principles and practices, with knowledge of quality management systems (QMS) and relevant standards (e.g., ISO 13485).

Skills required for success in this role:

• Ability to analyze complex technical and scientific information, identify patterns, evaluate evidence, and conduct thorough investigations to support sound, risk-based decisions.

• Strong ability to interpret data, assess trends, and use analytical tools to support complaint investigations, surveillance activities, and reporting.

• Working knowledge of complaint handling, medical device reporting, CAPA, and Field Action processes within a regulated medical device environment is a plus.

• Ability to communicate complex technical findings clearly and concisely in both written and verbal formats, including formal documentation and cross-functional discussions.

• High level of accuracy and consistency in documentation to ensure compliance and audit readiness.

• Ability to work effectively across R&D, Regulatory Affairs, Manufacturing, and other stakeholders to resolve issues and drive outcomes.

• Self-directed, accountable, and proactive in identifying improvement opportunities, adapting to regulatory changes, and strengthening post-market processes.

• Excellent communication skills, both written and verbal, to ensure clear and proper documentation of records.

• Ability to drive and deliver timely, customer-focused solutions.

• Proficient in Microsoft Office, specifically Excel, PowerPoint, and OneDrive. Additionally, data analytics skills, including PowerBI or similar professional analytical software, are desired.

• Open to learning and working in a collaborative team environment.

Ability to work on site preferred, consideration may be given to remote workers.

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:

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, 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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