Rod Atkins
Jupiter,Fl
Summary
Team SME for Global CAPA investigation, closure and regulatory impact assessment. Leading device client assisting with warning letter response. 3Rd part assessments and QMS integration projects Detail-oriented Software Consultant with 15-year backg2round designing, configuring and testing software. Comprehensive knowledge of software development lifecycles. Excellent analytical and documentation skills with remarkable project management abilities.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Sr. Quality Systems Consultant
Leading Global Device Company
2023.01 - Current
- Joined efforts in Jan
- 2023 as Sr
- Quality consultant leading existing staff in complaint, design, CAPA, NC management and FDA investigations to address FDA warning letter for High Risk CAPA investigation commitments
- In July 2023, transitioned to a Global remediation role to support EMEA and Japan teams in efforts to unify Global approach to investigations and to lead teams in remediation efforts and backlog of investigations
- May 2024, assumed additional responsibilities to manage 3rd party audit responses working with key leadership to draft Corporate response and corrective action plans for Market Quality Global teams
- June 2024
- 3rd project extension through Dec
- 2024
Director of Quality
Accelus-Integrity Implants
2021.04 - 2022.07
- Direct QMS & Compliance leadership responsibility over two site locations in Fla and CO
- Directed team of (18) engineers & quality inspectors across Supplier Mgt, Post Mkt, CAPA, NC, Design Quality, Document Control, Training & Audits
- Managed phase one of QMS integration between Fusion Robotics and Integrity Implants dba Accelus
- Accelus experienced remarkable growth for a late-stage start-up and I directly lead operations quality expansion efforts for incoming inspection, inventory management, reduced cycle time and automation efforts
- Reduced pending lot inventories by 70%/YOY and reduced backlog inventories in QC inspection by 35%
- Onboarded key engineering talent to the team to fuel growth and combined company initiatives
- Directed Class II recall filings for pedicle screws in Q1 2022 associated with legacy supplier and design issue
- Revised procedure controls for Complaint, NC, MDR and Supplier Quality to streamline and reflect merging BUs
- Direct site ISO 13485 & MDR compliance training program and initiatives In Jan
- 2022
- 2022, launched site’s first Quality KPIs program in Jan 2022
- Implemented revised supplier evaluation and KPI performance tracking program in cooperation with purchasing, supplier quality and product development to improve vendor management program/selection
- Lead 65% reduction and closure of aging Complaint, CAPA and NC investigations during first year.
Quality Manager
Zimmer Biomet, Dental
2019.10 - 2021.05
- Quality leadership position with ZB-Dental group including Quality and CAPA Manager in my 5-year tenure
- Direct hire based on efforts during a seven-month Supplier Quality remediation project in Warsaw
- Promoted to lead combined team of 18 engineers across Complaint management, Supplier and CAPA engineering
- Streamlined the complaint engineering, MDR assessment and integrated cross function PD, Sustaining and complaint investigation teams
- Directed supplier focused program to reduce NCs in 2020 resulting in a 40% reduction YOY
- Directed supplier-based audit program during Covid-19 through remote assessment and qualifications
- Implemented Skip Lot inspection and multiple reduced inspection programs for Key Preforming Suppliers
- Managed and delivered 1.6M operating budget
- Implemented (6) supplier-based cost saving programs delivering 350K savings in FY 20
- Maintained Quarterly Supplier performance levels above 90% for 95% of Class A/B supplier base
- Lead and directed two supplier-based recalls in 2020 due to failed SCN communication from supplier to ZB.
CAPA Program Manager
Zimmer Biomet, Dental
2017.04 - 2019.10
- Hired to address backlog of 80+ open legacy CAPAs and drive CAPA closure
- Lead CAPA efforts to address FDA warning letter observations in CAPA from 2016
- Zero CAPA findings in Qhub and Corp Audit subsequent audits in 2018/2020
- Returned CAPA program to positive KPI status across all four metrics in under two years
- Achieved steady state of < 20 open CAPAs by two-year goal mark of April 2019
- Site chosen twice in 2018 and 2019 for highest performing CAPA system in the ZB operations network
- Focus on Class II, IIb, combination and skin graft products.
Senior Quality Engineering, Engineer/Audits
Zimmer Biomet
2016.08 - 2017.04
- Consultant leading a comprehensive review of 500 Tier I/II suppliers with focus on special process validations and GHTF compliance
- SME for leading remediation and implementation of corrective actions focusing on packaging, labeling, sanitation, passivation, sterilization, and welding validations
- Risk Management Team Member-review written validations submitted by project team SMEs for gap assessment and compliance per site protocol.
CAPA Program Manager
Depuy Synthesis-JNJ
2014.02 - 2016.07
- CAPA investigation responsibility across site and for the Synthesis Power Tools division
- Site lead for QMS gap, correction and audit preparation and response to FDA findings
- I managed two major CAPA Remediation Projects focused on Legacy CAPA clean up, remediation investigation and steady state CAPA improvement initiatives
- Directed consultant team that reduced open CAPAs from +300 to target steady state volume of 60 in 06/2016
- Conducted all EtQ CAPA and Audit system training programs across PBG and Synthes European sites
- Remediated CAPAs & Audit actions and achieved no new systemic findings during third party QHub and FDA
- Launched CAPA procedure enhancements on forecasting, root cause assessment and effectiveness monitoring
- Achieved site metric compliance in Feb 2015 after the effective review and closure of +500 open CAPA actions plans and EMs for: Timeliness, Aging and Effectiveness Monitoring.
QMS FDA-Site Project Manager
Depuy Synthes
2012.10 - 2014.02
- Site PMO with Quality remediation program responsibility reporting directly to site Dir of Quality
- Managed and directed 120+ Consultants initially across: Supplier Quality Complaints, CAPA, NC, Validation, Process Engineering, Inspection and CSV work streams
- Focus on CAPA, Supplier SCAR, and initial review of Complaint, MDR and Field Action remediation efforts during first six months of the project
- Managed Project Agility and Corporate Project tracking plans for site Director of Quality and Corporate Compliance Teams and Corporate Report out responsibilities to DePuy Synthes Global Remediation Team
- Work stream lead for Q-Hub and FDA re-inspection and support efforts in 2013 and 2014 audits through action plan reviews, and front and back-room audit leadership roles
- Directed site remediation of +30,000 complaint record reviews in first six months in the position
- Conducted Synthes Swiss division site CAN/CAS ISO 13485 gap assessment audit and implemented Swiss/OUS compliance plan-two locations
- Accepted full time position with JNJ in Feb 2014 to direct and lead CAPA and Audit Management programs.
Senior Quality Systems Consultant
Pfizer
2012.05 - 2012.06
- Conducted all OOS batch release through NC & Validation and NC investigations for leading liquid pharmaceutical client located in NC
- Focus on manufacturing investigations & batch release investigations through 3rd party QHub approvers
- Aggressive site effort through consultant mix to address warning letter and multiple part 210 & 211 compliance gaps.
Sr. Quality Systems Engineer
Perrigo Florida
2011.01 - 2012.02
- Managed all Complaint, CAPA, Supplier SCAR and Process Improvement programs for this OTC private label pharma facility
- Perrigo announced closure of Florida facility in Oct 2011 and accepted consultant opportunity.
Quality Manager
Invacare Corporation
2006.04 - 2009.06
- Promoted in 2006 to lead the start-up business integration of all consumer returns, supplier quality product evaluation, failure investigation and complaint management programs
- Global Quality, (FDA Part 820 & ISO 13485 Compliance), Respiratory and Sleep Devices.
Lead internal auditor
Invacare
2004.03 - 2006.04
- For Part 820 FDA ISO 13485 compliance for Invacare's 12 global manufacturing operations
- Championed efforts with our international manufacturing and engineering teams to improve product quality and achieve systemic FDA QSR & ISO compliance for Class II and III medical device and component production.
Education
BA - Poly Sci & Economics
The Ohio State University
Columbus, OHMBA -
Regis University
Denver, CO05.2003
Skills
- QMS Remediation & FDA 483 response
- Leadership of Global CAPA development and program execution
- CAPA,Complainant and Deviation investigations
- Complaint and Adverse event reporting
- Supplier Quality program lead
- Team leadership and development
- Program and fiscal management
Certification
- EU MDR Requirements Training- ZB 01/2020
- ASQ ISO 13485 Lead Auditor Certified 01/2012 & 2016
- J&J 2016, Seminar & Corporate trainings on ISO 14971 and 21 CFR part 820,110,111,113 -01/2012
- Six Sigma Green Belt-Invacare -01/2008
- CAPA Academy Site Lead & Trainer-ZB 2017/2018
- Zimmer Biomet Lead Auditor-2018-2020
- SQF-Safe Quality Foods Practitioner-NSF June 2011, 2006
- Invacare Zero FDA Findings Award Recipient
- Invacare President's Award
- FDA Audit Performance Award -Invacare 2007
- ASQ Certified Quality Engineer- 2009
Timeline
Sr. Quality Systems Consultant
Leading Global Device Company
2023.01 - Current
Director of Quality
Accelus-Integrity Implants
2021.04 - 2022.07
Quality Manager
Zimmer Biomet, Dental
2019.10 - 2021.05
CAPA Program Manager
Zimmer Biomet, Dental
2017.04 - 2019.10
Senior Quality Engineering, Engineer/Audits
Zimmer Biomet
2016.08 - 2017.04
CAPA Program Manager
Depuy Synthesis-JNJ
2014.02 - 2016.07
QMS FDA-Site Project Manager
Depuy Synthes
2012.10 - 2014.02
Senior Quality Systems Consultant
Pfizer
2012.05 - 2012.06
Sr. Quality Systems Engineer
Perrigo Florida
2011.01 - 2012.02
Quality Manager
Invacare Corporation
2006.04 - 2009.06
Lead internal auditor
Invacare
2004.03 - 2006.04
BA - Poly Sci & Economics
The Ohio State University
MBA -
Regis University
- EU MDR Requirements Training- ZB 01/2020
- ASQ ISO 13485 Lead Auditor Certified 01/2012 & 2016
- J&J 2016, Seminar & Corporate trainings on ISO 14971 and 21 CFR part 820,110,111,113 -01/2012
- Six Sigma Green Belt-Invacare -01/2008
- CAPA Academy Site Lead & Trainer-ZB 2017/2018
- Zimmer Biomet Lead Auditor-2018-2020
- SQF-Safe Quality Foods Practitioner-NSF June 2011, 2006
- Invacare Zero FDA Findings Award Recipient
- Invacare President's Award
- FDA Audit Performance Award -Invacare 2007
- ASQ Certified Quality Engineer- 2009
Similar Profiles
Magali AlvarezMagali Alvarez
Strategic Accounts Specialist at Penumbra Inc.- Global Medical Device CompanyStrategic Accounts Specialist at Penumbra Inc.- Global Medical Device Company
Landi KapambweLandi Kapambwe
Customer Service Executive at iSON Xperiences Ltd - Leading Global CX Management CompanyCustomer Service Executive at iSON Xperiences Ltd - Leading Global CX Management Company
Deepak Krishna MurthyDeepak Krishna Murthy
Procurement Specialist at ABB Global Industries. Global Leading industry in Power and AutomationProcurement Specialist at ABB Global Industries. Global Leading industry in Power and Automation