Quality Compliance Fellow

Collaborates with Quality management to recommend, design and implement functional process improvements and guidance on compliance related matters. Your responsibilities will include: Supports Quality System PIR and Field Action sub-process through managing and supporting the PIR/FA process Provides focused quality systems compliance expertise within product development, operational, or system/services support. Provides project direction, coaching, and mentoring for quality system personnel at all levels of the organization. Supports the development team on strategy and compliance around, new product development, sustaining and HFA (Human Feasibility Assessment studies. Supports the organization by combing the business needs with compliance and setting the right strategy for success. Works as a liaison between Med Safety and PIR team, by working with the CIS team to drive data as needed to support complex CAPAs or PIR activities Works with CAPA team to support and drive risk evaluations and updates Bachelor's of science degree Minimum of 10 years relevant experience, preferably in medical device industry Master's degree and 7+ years relevant experience, preferably in medical device industry or other regulated industry Experience working on PIRs or evaluations supporting field action decisions Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements Excellent verbal / written communication, interpersonal, project management, and organizational skills; must be able to multi-task, and analyze information quickly Ability to communicate with all levels of the organization Must be able to work independently, lead and / or participate as part of a team Must be proactive, work independently, and be a contributing member of a highly visible team Must have working knowledge of Medical device product development cycle Must have experience working on NCEPs, CAPAs and Field Actions Prior experience working on Class III medical device projects Prior experience working on HFA (Human Feasibility Assessment) projects Prior experience leading teams on complex CAPAs Prior experience interfacing with auditors or investigators directly, supporting Quality System audits Design Quality experience