Sr. Quality Systems Analyst / Complaints
Plainsboro, NJ

Job Description

Overview

Responsibilities The Senior Quality Systems Analyst is responsible for identifying and applying analytical best practices to Quality System processes across Integra facilities. This person develops metrics and alert limits to facilitate consistent and timely reporting and action in key Quality System processes. This position offers opportunities to partner cross functionally to drive a clear strategy for compliance, provides high visibility and is established as a key position in a high performing team.

* Lead quality product and process metrics development and reporting for complaints and post market surveillance activities.
* Lead and continuously improve predictive quality analytics including forecasting, data gathering and modeling.
* This individual will execute other key projects as required.
* Leverage new data collection processes to minimize "hands-on" time & reduce collection errors.
* Communicate product data and trending results to other functional stakeholders (risk management, quality engineering, product development, operations).
* Work in a team environment with members of Quality on achieving team metric requirements.

Qualifications

* A minimum of a Bachelor's Degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline
* A minimum of 5 - 7 years of overall experience in the medical device/pharmaceutical industry.
* Regulatory Affairs Certified (RAC)
* Quality System Auditor (RABQSA, AQS, etc.)
* Experience with QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards is required.
* Experience with of 21 CFR Part 11 and Computer/Quality System Software validation, and EU MDR.
* Strong oral and written communication skills and effective interpersonal skills.
* Ability to multitask, prioritize and meet deadlines.
* Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.
* Experience synchronizing data and preparing presentations for senior leaders
* Ability to communicate well with all levels of management