Medical Device Devices
Resume:
Jeffery Mark Shields
Naples, Florida 34117
**************@*****.***
Phone 786-***-****
CORE COMPETENCIES
A career Medical Device Industry leader, specializing in Supplier Quality Specialist/ Validation Engineering trainer and Management/QMS consultant/ CAPA Specialist/ ISO13485/ISO9001 Certified Lead Auditor/ and Certified SIX Sigma Blackbelt (DMAIC). Experience working in Class I, II and III medical devices.
RELEVANT INDUSTRY EXPERIENCE
3/28/22 – 11/20/23 (Contract)
Medtronic (HVAD) CAPA Systems Specialist Supporting CAPA Activities
Led cross-functional teams in Root Cause Analysis of complex investigations. Ensured deliverables were met per project timelines. Facilitated product and process investigations from issue Identification, Investigation, Action and Effectiveness phases include Effectiveness monitoring activities. Documented tracking and progress of phases utilizing Trackwise software. Also, incorporated Six Sigma Principles to drive data analysis and decision making along with Root Cause Analysis, Critical Thinking, Technical Writing training and skills.
6/15/21 – 2/11/22 (Contract)
Balt Medical – Validation and Quality Systems Engineer for Extrusion for Medical Devices
Created Standard Operating Procedures and Work Instructions for Medical Device Manufacturer of Class 2 Devices. Also wrote Validation Protocols and Reports for various Manufacturing Processes. Worked on validation activities for transfer of product from California to France new facility.
6/1/2017 – 6/15/21 (Consultant)
Mark Two Engineering - Vice President of Quality of medical device components
Management of internal and supplier validations, supplier performance tracking, internal and external quality metrics, customer complaints, MRB and CAPA monitoring, investigation to resolution. Company Quality Representative in FDA and ISO inspections/audits. Authored responses and corrective actions for FDA/ISO 483/audit findings. Managed and participated in internal and supplier audits as part of supplier evaluation and acceptance. Executed capability studies and Gauge R & Rs on internal processes. Conducted PPAP activities per customer requirements to ensure we met all specifications and requirements for new product release including capability studies and quality plans by product.
12/15/16- 5/1/2017 (Contract)
Zimmer Biomet - Validation Engineering and Quality systems Specialist
Wrote IQ/OQ/PQ documents for validation of CNC equipment for orthodontic device applications. Responsible for the transfer validations required for moving product from West Coast facility to West Palm Beach Gardens location.
9/17/2012 – 11/11/2016
Arthrex Inc. – Supplier QA Systems and Validation Manager in Medical Device Orthopedics
Managed a team of supplier validation engineers and technicians responsible for working with suppliers to achieve validated process to meet FDA standards for all orthopedic medical devices. Responsible for Supplier change request process for supplier process change activities. Ensured process was documented and prioritized activities. Communicated with internal stakeholders of change requests activities schedules and timelines for activities of suppliers. Review and assist in TMVs. Performed onsite audits of suppliers QMS to ensure compliance to ISO13485 and ISO9001. Provided summary reports of audits and followed up with Supplier responses to closure of audit findings Created and managed the Master Validation Plan and validation strategies. Managed and co-generated validation protocols with team members, including IQ, OQ and PQ documentation for manufacturing processes and equipment for Domestic and European Suppliers to ensure compliance with FDA guidelines.
10//01/2011 – 09/01/2012
Stryker (MAKO Surgical) – Senior Quality Assurance Engineer in Orthopedic Robotic Applications
Responsible for validations for all medical device processes and equipment, responsible for CAPA and MRB investigation reports and investigations of customer complaints, writing validation reports, protocols, FMEAs, authoring relevant procedures and creating DMRs and DHFs files.
07/2010 – 11/01/2011
Arthrex Inc. – QA Engineer of Supplier Quality Systems in Orthopedic Medical Device Manufacturing
Responsible for validations for all medical device processes and equipment. Developed validation strategies and projects involving multiple departments and validation teams including supplier validations and development. Performed QMS supplier audits to ensure compliance to ISO13485 and or ISO9001 of all aspects of quality and manufacturing activities.
08/2008 – 4/1/2010
Watson Pharmaceutical Corporation - QA Senior Process Engineer in Pharmaceutical Drug Manufacturing
Responsible for generation of sampling plans and procedures per ANSI standards for incoming receiving and inspection of raw materials, writing CAPA investigation reports and root cause investigation of customer complaints. Reviewed and approved validation protocols and reports for packaging lines and equipment.
02/2003 – 08/2008
Boston Scientific Corporation - Manufacturing Engineer for Extrusion and Guidewire production
Responsible for all aspects of new products for medical devices product development (NPD), including protocols, work instructions, FMEAs, and all documents for NPD release. NPD release included transfer of undeveloped processes to Doral facility for further process improvement and validation at new location. Conducted capability analysis and specification changes as needed based on process capabilities.
01/2002 -02/2003
Haier Corporation – Senior Manufacturing engineer responsible for all aspects of thermoforming plastics for refrigerator manufacturing. Developed plastic thermoforming process with new equipment and new facility to production release.
01/1995 –10/2001
Cordis Corporation (J & J) – Staff Engineer/Extrusions for medical device manufacturer. Developed guiding and diagnostic catheters for Angioplasty applications.
EARLY CAREER DEVELOPMENT POSITIONS
Telectronics Pacing System - Injection Molding Manufacturing Engineer in medical device manufacturing Pacemakers/Defibrillators
General Electric - Process Engineer in refrigeration manufacturing (Extrusion, Thermoforming, Injection molding)
ADDITIONAL SKILLS, TRAINING AND EDUCATION
Illinois State University – Normal, Illinois - Bachelor of Science, Industrial Technology
Six Sigma Blackbelt Certification (Johnson & Johnson) 2001
Internal Auditor Training for 21 CFR Parts 820 & 11, ISO13485
AQS ISO 9001: Lead Auditor Training for Medical Devices (ISO 13485:2003) Cert. # Q16343
Minitab Statistical and Trackwise Software training
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