Description:
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).