The Quality Engineer will be responsible for providing technical acumen and data analysis for the Endoscopy division of the company for Post Market Reporting assessments (Periodic Safety Updates).
The Quality Engineer will have previous experience in PMS activities or equivalent. The analysis and reporting directly supports product sustainment activities assessing product performance for trends including signal escalation. The role identifies, analyzes, helps to investigate, monitors and documents trends at a product performance level for post marketing surveillance data as part of the EU MDR reporting requirements. The role communicates and educates management, R&D, marketing, Design Assurance, plant QA, clinical, and other departments, as well as potentially external customers about complaints monitoring trending and product performance.
Key Responsibilities
Work as part of the Post Market Surveillance Team in the development and generation of post market surveillance (PMS) plans and reports for the company's medical devices.
Collect, analyze, trend and report on safety data to proactively identify potential adverse safety risks or performance trends.
Provides clinical and safety data assessment of post-marketing events.
Collaborate with internal functions (Quality, Regulatory, Medical Affairs, Complaint Management, Manufacturing and R&D) to ensure compliance to applicable regulations, standards, and company procedures to help improve the quality of patient care.
Assist with Risk Management File Maintenance where necessary.
Support any additional EU MDR quality related tasks as required by the company Quality Systems
Qualifications
Bachelor's degree with an Engineering or Science background
5+ years of Medical Device engineering experience with BS,
3+ years with MS Previous experience with PMS activities or equivalent
Must have Microsoft office skillset Excellent communication
Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.