Summary
Overview
Work History
Education
Skills
References
Affiliations
Accomplishments
Timeline
Generic

Christopher Wood

Wesley Chapel

Summary

Accomplished Director of QA/RA with extensive experience throughout multiple medical device companies, driving regulatory compliance and optimizing quality management systems. Expert in design controls, risk assessment and corrective actions, I successfully led initiatives that reduced non-conformance reports by 47%. A collaborative leader, I excel in fostering cross-functional partnerships to achieve strategic objectives.

Overview

26
26
years of professional experience

Work History

Director QA RA

React Health
Dublin
07.2024 - 09.2025
  • Ensured compliance with industry regulations through a program of continuous QMS reviews and corrective and preventive actions.
  • Collaborated with senior leadership to establish short and interim term strategic objectives.
  • Developed comprehensive project plans detailing timelines, goals, budgets, and staffing requirements.
  • Analyzed customer feedback data to identify trends in product performance and quality.
  • Coordinated with regulatory and notified bodies to maintain adherence to laws and standards.
  • Led change management and risk mitigation initiatives to respond effectively to compliance concerns and organizational demands.
  • Cultivated strong relationships with OEMs by responding promptly to inquiries or complaints.
  • Reviewed internal reports and identified areas of risk or potential cost savings.
  • Prepared presentations for board meetings summarizing quality issues within the company.
  • Identified opportunities for process optimization through data analysis.

Sr Design Quality Engineer

React Health
02.2023 - 07.2024
  • As Sr. Design Quality Engineer, I assured that both organic and OEM products conformed to quality standards, and compliance with the regulatory requirements.
  • Partnered with cross-functional team members ensuring implementation, improvement, and compliance of the Quality Management System (QMS) while meeting business needs.
  • Initiated, reviewed and approved Engineering Change Orders.
  • Ensured product and process specifications were defined and met regulatory requirements, utilizing risk management and mitigation tools.
  • I implemented design controls for new products, and developed and maintained risk management files.
  • I identified gaps and implemented improvements in the design control program.
  • I also participated in and led CAPA program to ensure timely investigation, implementation of corrections/corrective actions and effectiveness.
  • Led external regulatory audits and inspections.

QA Manager

02.2021 - 02.2023
  • With a change in corporate leadership, I resumed my prior role as QA Manager for North American sites in Bradenton, Florida, and Morrisville, North Carolina, that I held from June 2012 to May 2019..

Director Quality Assurance and Regulatory Affairs

Ascom (Sweden) AB
Bradenton
05.2019 - 02.2021
  • I assumed the role and responsibilities of the Director Quality Assurance and Regulatory Affairs with respect to corporate wide QA / RA reporting to the COO.
  • I was responsible for product surveillance, vigilance, reporting, supplier correction action, product risk management, quality system administration, external audits and / or inspections, internal audits for 18 global locations.
  • Facilitated a contract mock FDA audit to train staff and bring visibility to high risk and non-conforming processes and execution.

Patient Systems - Site Quality Assurance and Regulatory Affairs Manager, Nurse Call Systems, Deputy Director Quality Assurance and Regulatory Affairs

Ascom (US) Inc.
Bradenton
06.2012 - 05.2019
  • A site Quality Assurance and Regulatory Affairs Manager, I worked with the new corporate (Ascom) ownership to migrate the business to another quality management system.
  • In addition to maintaining ongoing compliance with respect to product development of the current product, Nurse Call Systems inherited responsibility for another Nurse Call group that markets Nurse Call Systems globally necessitating an accelerated learning curve on global compliance requirements.
  • I worked with corporate QA/RA to identify best practices amongst multiple sites in Florida, North Carolina, Netherlands, Australia and Sweden.
  • I coordinated with multiple site QA/RA representatives to accelerate quality management system maturity in a corporate environment with limited medical device history.
  • I have developed additional local work instructions and standard operating procedures to bridge the site to the Ascom QMS.
  • I developed completely new training and compliance training content.
  • The deployment of Design Controls training to the development group in the Netherlands resulted in a 47% reduction in NCR’s in the first three quarters following execution.
  • I performed cross-audits amongst other Ascom sites and training for both the US site and other sites.
  • I worked with two development (engineering groups) in US and Europe to manage design controls and compliant product development across 10-12 programs simultaneously.
  • I maintained local site quality plans, quality policies and quality manuals and the attendant SOP’s and work instructions.
  • As the site Risk Coordinator for product development, I conducted hazard analysis and risk assessments for Nurse Call system products and consult with other product lines in the execution of risk management.

Site Quality Assurance and Regulatory Affairs Manager, Nurse Call Systems

GE Healthcare
Bradenton
07.2009 - 06.2012
  • As Site Quality Assurance and Regulatory Affairs Manager, I was responsible to transform a newly acquired business never exposed to medical regulations and quality management systems (QMS) rigor to one with solid understanding of these principals while fostering an environment that embraces regulatory compliance.
  • I was able to leverage the breadth of my practical QA/RA and engineering design and project management experience, my expertise in applying the quality management systems in design and development, and my ability to coach & mentor, to achieve a practical, working application of the quality system regulations.
  • I authored and deployed local work instructions and standard operating procedures to bridge the business to the GE Healthcare QMS.
  • I developed and oversaw the application of training programs, developed and institutionalized quality metrics and data collection.
  • I facilitated the Nurse Call Systems migration to GE Healthcare tools & systems.
  • I directed and implemented the adoption of systems supporting complaint handling and post market event reporting, CAPA, Product Data Management, System Problem Reports, Supplier Corrective Actions, Defect Tracking, Configuration Management, Document Control & Record Management, and Online Training.
  • I oversaw and directed product development to FDA quality system regulations and ISO 13485 compliance.
  • The site received it’s first (surprise) FDA inspection and obtained its ISO 13485 certification following notified body audit, both with no findings.
  • I authored new hazard analysis, risk assessment and control records and failure mode effects analysis (FMEA) for Nurse Call System products supporting the installed base in post market event reporting and engineering in new product introductions (NPI).

Quality Engineer, Clinical Systems, Monitoring Solutions Division

GE Healthcare
Milwaukee
07.2008 - 03.2009
  • As Quality Engineering Leader, and working remotely from home office, I supported product design programs and installed base engineering projects (bedside vital signs monitors) developed at the GE Healthcare facilities in Milwaukee and Helsinki (formerly Instrumentarium).
  • I provided guidance and direction with respect to design controls and regulatory requirements to program teams ensuring that the program documentation meets or exceeds requirements.
  • I was the quality engineer for 20 different NPI and maintenance programs across the Monitoring Solutions business segments and the leading promoter and mentor for the new Design Controls processes for Monitoring Solutions.
  • I was a core team member of the key business program that delivered the new software platform for the next generation patient monitors.
  • I mentored two new Quality Engineers in Helsinki to effective team members in short time frame.
  • I closed or supported the closing of over 100 CAPA cases.
  • I supported internal (General Audit Council) and external (FDA and Notified Body) audits throughout multiple GE Healthcare facilities including Helsinki and Bangalore.

Quality Engineer, Clinical Systems, Monitoring Solutions Division

GE Healthcare
Tampa
09.2007 - 07.2008
  • As Quality Engineering Leader, I supported product design programs and installed base engineering projects (bedside vital signs monitors) developed at the GE Healthcare facility in Milwaukee to ensure compliance to GE Healthcare Quality Standards and Design Controls as well as FDA (Food and Drug Administration) and regulatory (ISO 9001, ISO 13485) requirements.
  • I drove and managed quality compliance in product CAPA (corrective and preventive action) for the monitoring products developed in the Tampa facility.
  • I oversaw and audited the implementation and rollout of new and updated compliance procedures and the implementation and remediation of process level CAPA at the Helsinki facility.
  • I managed the Tampa site DPC (Design Process Committee) maintaining the currency of engineering design processes to corporate and regulatory requirements.
  • Within GE Healthcare, Clinical Systems as a whole, I was a member of the Engineering Process Council, the body that effected the implementation of new and revised engineering design processes to all divisions.
  • I supported internal and external (FDA and Notified Body) audits throughout multiple GE Healthcare facilities.

Lead Program Integrator (Project Manager), Perinatal Systems Engineering

GE Healthcare
Tampa
10.2003 - 09.2007
  • In this role I was responsible for the prioritization, scheduling and execution of installed base programs including engineering design changes, product initiatives, field modifications and product compliance (regulatory and environmental).
  • I managed a diverse international team of locally based (Tampa), domestic based (US) and remote international based (India) resources to support, execute, drive and implement through to operations, engineering design changes at every level, and across all engineering disciplines (electrical, software, and mechanical).
  • I delivered a major redesign project of the 120’s Series Fetal Monitor three months early (16%) and under budget (20%).
  • I also managed and drive programs to meet domestic and international regulatory WEEE (waste electrical and electronic equipment) and RoHS (Restriction of Hazardous Substance) compliance initiatives throughout the world.
  • From July 2007 to September 2007, I managed the migration of the entirety of the Maternal Infant Care product development activities from Tampa, Florida to Bangalore, India including the transfer of physical and intellectual property assets.
  • I was also responsible to effect the on time decommissioning of the IT infrastructure and final closure of Tampa facility.

Software Engineer, Perinatal Systems Development

GE Medical Systems, Information Technologies
Annapolis
01.2000 - 10.2003
  • I completed and delivered, on time, an extension to a previously developed optical drive, patient archiving system.
  • This extension application leveraged the archive software written for NT to facilitate the conversion of legacy data from WORM platters created under OS/2.
  • I completed multiple projects to complete the migration of existing Clinical Information System applications from Modula-2 and OS/2 to C++ and NT.
  • These included a Patient Data Daemon configuration tool, conversion of command line system commands to a Graphic User Interface, and Graphical Chart Printing.
  • I undertook the task of converting the code base of over 11,000 Visual Basic and SQL files from a recently acquired division to the Rational ClearCase Configuration Management solution (in lieu of Visual Source Safe).
  • I implemented installation, deployment and maintenance strategies as well as performing all administrative tasks and CM tasks.
  • I also reduced code volume by over 30% by identifying, reducing and consolidating redundant code.
  • During this period I also maintained conventional programming responsibilities in the commercialization of the new application in Visual Basic and Microsoft SQL.

Education

RABQSA Lead Auditor Certification - ISO 13485

Oriel Stat-A-Matrix (UL)
06.2011

Computer Science -

University of New Haven
West Haven, CT

Information Technology Program in SQL -

University of Phoenix
Columbia, Maryland

Professional Development Course Rationale Rose IDE -

Learning Tree International
Reston, Virginia

Technical Degree -

Connecticut School of Electronics
New Haven, Connecticut

Skills

  • Regulatory compliance
  • Quality management systems
  • Design controls
  • Risk assessment
  • Corrective and preventive actions
  • SDLC (Software Development Lifecycle)
  • Audits and managing external audits
  • Post Market including Complaints, Reporting, Recalls, Advisory Notices

References

Available Upon Request

Affiliations

  • 17 Years as a high school and travel baseball coach

Accomplishments

  • Multiple Project Management Awards from GE Healthcare and Marquette Medical Systems

Timeline

Director QA RA

React Health
07.2024 - 09.2025

Sr Design Quality Engineer

React Health
02.2023 - 07.2024

QA Manager

02.2021 - 02.2023

Director Quality Assurance and Regulatory Affairs

Ascom (Sweden) AB
05.2019 - 02.2021

Patient Systems - Site Quality Assurance and Regulatory Affairs Manager, Nurse Call Systems, Deputy Director Quality Assurance and Regulatory Affairs

Ascom (US) Inc.
06.2012 - 05.2019

Site Quality Assurance and Regulatory Affairs Manager, Nurse Call Systems

GE Healthcare
07.2009 - 06.2012

Quality Engineer, Clinical Systems, Monitoring Solutions Division

GE Healthcare
07.2008 - 03.2009

Quality Engineer, Clinical Systems, Monitoring Solutions Division

GE Healthcare
09.2007 - 07.2008

Lead Program Integrator (Project Manager), Perinatal Systems Engineering

GE Healthcare
10.2003 - 09.2007

Software Engineer, Perinatal Systems Development

GE Medical Systems, Information Technologies
01.2000 - 10.2003

RABQSA Lead Auditor Certification - ISO 13485

Oriel Stat-A-Matrix (UL)

Computer Science -

University of New Haven

Information Technology Program in SQL -

University of Phoenix

Professional Development Course Rationale Rose IDE -

Learning Tree International

Technical Degree -

Connecticut School of Electronics

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