Post-Market Surveillance Quality Engineer

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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