Summary
Overview
Work History
Education
Skills
Timeline
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James Steele

Warrenville,IL

Summary

Proven and results-oriented medical device engineer and quality professional with a passion for ensuring safety and performance through efficient application of industry standards and regulatory requirements. Trusted subject matter expert in Design Control, Risk Management, Post-Market Surveillance, and Clinical Evaluation with tactical and strategic experience throughout combination product and medical device lifecycles.

Overview

7
7
years of professional experience

Work History

Manager, Post-Market Device Quality

AbbVie Inc.
01.2023 - Current
  • Manage CAPA process for Devices & Combination Products, ensure NCRs/CAPAs are opened, as appropriate, to drive meaningful improvements
  • Oversee timely completion of CAPAs using risk-based approach
  • Provide technical oversight and ensure that DHFs are appropriately updated for Ops-led changes
  • Drive best-in-class documentation
  • Maintain relevant business systems (e.g., Polarion ALM) with relationship to DHFs
  • Manage Potential Trend Evaluations (or similar) stemming from post-market data, ensuring team completes investigations in timely manner
  • Use evidence-based information to escalate potential trends for further review
  • Manage Post-Market Reporting process (e.g., PMCFP/PMCFR, PMSP/PMSR/PSURs, PRER, CER, etc.), providing tactical direction and assistance to internal and external stakeholders
  • Maintain process in alignment with current MDCG, ISO standards, and regulations
  • Serve as SME during regulatory inspections in primary areas of responsibility
  • Generate and maintain metrics, as requested, and use data to drive continuous improvement in assigned functional areas
  • Escalate discrepancies and confirmed or potential Quality issues to management
  • Propose and lead projects intended to drive meaningful improvements in MDC
  • Built team of 7 direct reports and hired 5 individuals.
  • Ensure direct reports are given opportunities to learn, grow, and utilize their strengths
  • Ensured team maintains patient-centric focus.

QA Device Products Manager - Risk Management

AbbVie Inc.
04.2021 - 12.2022
  • Primary Risk Management SME representing on-market medical devices and combination products
  • Created and Maintained product Risk Management deliverables across brands
  • Contributed to process improvement and integration initiatives against ISO 14971 requirements
  • Performed Risk Management documentation assessments in context of CAPA and Change Activities
  • Drove design control through risk management activities
  • Business System Owner of global Design Control and Risk Management documentation and life-cycle management tool.

Program Manager, Combination Products & Devices

AbbVie Inc.
05.2020 - 03.2021
  • Acted as Primary Responsible QA role on diverse range of combination product development projects from dosing cups to infusion pump systems
  • Applied knowledge of regulations and standards to development of combination products & medical devices
  • Guided teams through design control process, ensuring implementation of quality system and regulatory requirements
  • Conducted meetings and communications with third party suppliers and partnered with Supplier QA (GxP Compliance) to ensure implementation of supplier controls
  • Represented Combo QA on the Risk Management COE, ensuring alignment between operations and R&D as well as integration between drug and device
  • Identified quality system gaps and authored or contributed to wide array of new process and process improvement initiatives applicable to GMP activities
  • Authored training modules and provided instructor led training to business partners
  • Supported internal audit in both front and back room
  • Managed internal and supplier changes.

Quality Engineer, Combination Products & Devices

AbbVie Inc.
01.2017 - 05.2020
  • Converted to full employee from previous contract position
  • Applied knowledge of regulations and standards to development of combination products & medical devices
  • Supported risk management activities and contributed to creation and revision of deliverables
  • Anticipated quality issues through preventative actions and resolved existing issues
  • Contributed to development and improvement of Quality System processes
  • Assisted in preparation and support of regulatory agency and internal audits.

Engineer, Combination Product Development (Rotation)

AbbVie Inc.
08.2018 - 01.2019
  • 6-month rotation in the R&D Engineering Testing and Analysis Group
  • Developed test methods and performed engineering confidence and design verification, and incoming testing
  • Authored verification protocols and records
  • Performed statistics analysis on normal and non-normal data sets
  • Received training on various laboratory equipment and assisted in equipment validation.

Engineer I

Ventura Solutions, LLC (AbbVie, Inc.)
09.2016 - 12.2016
  • Contract supporting R&D in the development of combination products through the quality organization
  • Ensured integration and support of Quality System and federal regulations
  • Performed various internal and 3rd party design control review activities
  • Identified gaps and improvement opportunities within DHF and established traceability between deliverables
  • Worked closely with systems engineering on risk management deliverables.

Education

Master’s Degree in Biomedical Engineering -

University of Illinois - Chicago
Chicago, IL
05.2016

Bachelor’s Degree in Biology and Neuroscience -

Augustana College
Rock Island, IL
05.2013

Skills

  • Verbal and written communication
  • Negotiation and Conflict Resolution
  • Work Planning and Prioritization
  • Process Development & Improvement
  • ISO 13485, Medical Device Quality Management Systems
  • ISO 14971, Medical Device Risk Management
  • FDA CFR 82030, Design Controls
  • Regulation (EU) 2017/745, EU MDR
  • IEC 62366, Medical Device Usability Engineering
  • ISO 20417, Medical Device Information Supplied by Manufacturer
  • ISO 15223, Medical Device Symbols

Timeline

Manager, Post-Market Device Quality

AbbVie Inc.
01.2023 - Current

QA Device Products Manager - Risk Management

AbbVie Inc.
04.2021 - 12.2022

Program Manager, Combination Products & Devices

AbbVie Inc.
05.2020 - 03.2021

Engineer, Combination Product Development (Rotation)

AbbVie Inc.
08.2018 - 01.2019

Quality Engineer, Combination Products & Devices

AbbVie Inc.
01.2017 - 05.2020

Engineer I

Ventura Solutions, LLC (AbbVie, Inc.)
09.2016 - 12.2016

Master’s Degree in Biomedical Engineering -

University of Illinois - Chicago

Bachelor’s Degree in Biology and Neuroscience -

Augustana College

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James Steele