Job Description Summary
You will support manufacturing of peripheral interventional devices. This role will represent quality interests and concerns on day-to-day quality operations to ensure conforming materials are available for manufacturing and customers.
Main Responsibilities:
* Ensures compliance with quality system requirements as defined by BD Technologies, procedures, FDA QSR, ISO 13485, and applicable international and national standards (e.g., EN, ASTM).
* Provides Quality representation to support the day-to-day operation of the business
* Experience in risk management tools, specifically PFMEA, and how process changes can impact existing risk assessments.
* Experience in validation, including assessing the impact of changes to existing processes and the review and approval of process validation documentation (IQ, OQ and PQ)
* Ensuring continued material compliance and timely disposition of non-conforming materials from Incoming Quality Control or Manufacturing Processes.
* Demonstrated experience in the use of root cause analysis tools and problem-solving techniques.
* Supports continuous improvement initiatives related to quality processes to drive performance and compliance.
* Demonstrated experience in change control systems, including creating/updating various documents or procedures and reviewing quality documentation to ensure accuracy and compliance with procedures and regulations.
* Demonstrated ability to use data analysis to drive solutions that can improve the quality of a process, such as NCMR reduction, defect reduction, inspection improvements, etc.
* Supports metrics and regulatory reporting following the relevant Corporate, Local and International Requirements.