David Lockridge
North Ogden
Summary
Knowledgeable Quality Leader with proven background in senior leadership roles, driving strategic initiatives and supporting operational execution, enabling effective risk based compliance strategies and fostering professional development and organizational growth. Successfully led cross-functional teams to achieve key business objectives, enhancing operational efficiency and stakeholder satisfaction.
Strong focus on fostering team and cross functional collaboration and adapting to changing business needs. Highly skilled in leadership, communication, and delivering impactful results.
Overview
43
43
years of professional experience
1
1
Certification
Work History
Senior Director of Global Quality Assurance
Merit Medical Systems Inc
08.2018 - 02.2025
- High volume, high mix manufacturer of Class 1, 2, and 3 medical devices (surgical instruments and accessories, interventional cardiology, endoscopy).
- Global QMS process harmonization and optimization champion. Multisite responsibility.
- Designed and implemented global ISO 14971 Risk Management process for 230 product families to support and sustain EU MDR Certification. (2019 - 2025)
- Developed and implemented EU 745:2019 global Post Market Surveillance process to enable and maintain EU and ROW market access. (2019 - 2025)
- Improved customer complaint closure metrics from 80% > than 60 days to 98% < 30 days in 12 months (2023/2024).
- Improved change control (ECN) cycle time from 85% > than 60 days to 95% < than 45 days (2023/2024).
- Strengthened CAPA process to reduce total CAPA by 72% (2023/2024) through robust investigation process and root cause analysis training.
- Managed rapid development of QMS, regulatory and critical supplier support for Covid-19 test kits under State of Utah EUA to support global critical need. (2019/2021).
- Improved new employee orientation, training curriculum and OJT structure to move new employees to production in 2 days (from 14 days). 2024.
- Directed execution of business transformation initiatives to drive performance, optimize QMS processes and successfully execute global compliance requirements in support of aggressive product acquisition strategy.
Site Quality Director, Drugs and Devices
Fresenius Medical Care NA
07.2013 - 08.2018
- Site Quality Management Representative for Drugs and Devices. 3500 employees (QA 160), 24/7 365, high volume medical devices (dialyzer, blood tubing sets, accessories) and drug products (dialysate, saline). Multisite responsibility.
- ASQ CPGP Pharmaceutical Professional.
- Responsible for FDA and external agency audit prep, execution and relationship management.
- Global remediation / QMS integration leader (2013) Warning letter remediation leadership (2013/2016).
- Harmonized Device and Drug requirements into One Global QMS. Implemented and sustained global metrics for Design Change (> 90% effective), Change Control (>120 days to < 30 days), CAPA timeliness (no overdue, >95% on time/phase, >95% effective), complaint closure (< 20 days), NC / Investigation closure < 25 days), < one 483 finding / ZERO WL per annual FDA).
- Implemented critical supplier development / specification improvement initiative to provide redundancy for all single source suppliers to achieve > 5% (target) material and API YOY cost reductions.
Senior Remediation Consultant
Quintiles
04.2013 - 06.2013
- Provide on-site rescue remediation leadership in support of critical of foreign based (Singapore) supplier performance issues (via Johnson & Johnson).
- Quickly established collaborative approach and platform for trust with local management team.
- Implemented QMS/tactical assessment remediation plan to close and verify 26 QMS compliance gaps within 90 days.
- Accelerated and drove completion of all project tasks and remediation objectives in 75 days.
Senior Quality Director
Siemens Healthcare Diagnostics
08.2010 - 02.2013
- Multisite QMS responsibility (Illinois, Tennessee and Oxford UK).
- Corporate LEAN / Continuous Improvement Steering Team Leader. 12 projects completed 2010/2012.
- Product reliability / warranty cost reduction project yielded 15% reduction in Service Calls for three common failure modes (2011). Conducted root cause analysis for process failures, leading to the development of effective preventive measures.
- Warning letter remediation leadership for Knoxville and Illinois locations. Emphasis on QMS re: SaMD, Design Controls. Successful WL close out ~18 months.
- Implemented QMS process design, project framework and execution metrics for AGILE / Iterative SW Development teams. Standardized QTRLY SW release schedule (vs. bi-annual).
- Achieved departmental objectives by setting clear performance metrics and regularly reviewing progress against targets.
Quality Director
General Electric Company
05.2006 - 08.2010
- Market leader in C-Arm / Fluoroscopic X-Ray equipment and SW. Install base: ~350k
- 1 of 2 Consent Decree Remediation Leaders hired for 2006 OEC WL.
- Managed 13 remediation teams working on complete overhaul of OEC QMS. Key accomplishments included process design for ISO14971 Risk Management (rolled out throughout all GE Healthcare MFG locations) and new customer complaint evaluation and reporting process (critical CD finding).
- Managed local OEC QA team and ~200 contractors over 19 months to achieve approval to lift CD stop ship (9900 Elite Product Line).
- FDA point of contact for remediation plan progress reports, updates and follow up requests.
- Concurrently managed quality operations and QMS systems to support install base servicing and equipment refurbishment during CD.
- Managed external regulatory agencies (TUV, Canada, Japan, China, etc.) concurrent with FDA to facilitate reconciliation of license restrictions related to CD.
Director of QA/RA
CooperVision
01.2006 - 05.2006
- High volume contact lens manufacturer. Multisite QMS and regulatory responsibility.
- High focus on OPS Quality and QMS efficiency.
- Exited position under mutually agreed upon terms to accept position with GE Healthcare.
Director of Supply Chain
Quickparts
02.2005 - 12.2005
- Quick fab custom part start up company.
- Hired to implement ISO 9001 QMS to provide access to medical device quick fab parts. Initiative later abandoned.
Manufacturing Engineering Manager
Aksys
09.2003 - 02.2005
- In-home hemodialyses start up company
- Wore many hats. Quality, Regulatory, Design Engineering, Supply Chain, Contract Management. Versatile and energetic culture.
- Great concept, difficult daily equipment sterilization challenges led to excessive service expenses. Dialyzer reliability was main failure mode.
- Venture funding ceased as wide scale commercialization plans were stalled by reliability issues.
Job History Not Covered in Resume
Various
01.1982 - 02.2005
- VP of Administration - AFC Worldwide Express. Atlanta Ga. Third party freight management. ISO 9000. (2003)
- Managing Director - Rusch International. Ex-pat assignment in Malaysia. High volume plastics and latex commodity medical devices. FDA/ISO. 1997-2002
- Business Unit Manager - Healthdyne Technologies. Atlanta, Ga. CPAP and Baby Monitors. FDA/ISO 1994-1997
- Rockwell International Missile Systems Division, Atlanta, Ga. DOD Quality Management and Quality Systems. 1982 - 1994.
Education
Bachelor of Science - Electrical Engineering
Brigham Young University
Provo, UTSkills
- FDA Device and Drug (820, 210/211), ISO 13485, MDSAP, EU MDR 745:2019 and related ROW regulations
- Customer communication, relationship management
- Team-Oriented Leadership
- Cultural Change Leadership
- Strategic Policy Design
- Results management - metrics / KPI development and execution
- Professional staff development / succession planning
- Relationship management with Regulatory bodies
- Risk based assessment and evaluation
Certification
- ASQ Pharmaceutical GMP Professional
- ASQ Risk Management Certification
Timeline
Senior Director of Global Quality Assurance
Merit Medical Systems Inc
08.2018 - 02.2025
Site Quality Director, Drugs and Devices
Fresenius Medical Care NA
07.2013 - 08.2018
Senior Remediation Consultant
Quintiles
04.2013 - 06.2013
Senior Quality Director
Siemens Healthcare Diagnostics
08.2010 - 02.2013
Quality Director
General Electric Company
05.2006 - 08.2010
Director of QA/RA
CooperVision
01.2006 - 05.2006
Director of Supply Chain
Quickparts
02.2005 - 12.2005
Manufacturing Engineering Manager
Aksys
09.2003 - 02.2005
Job History Not Covered in Resume
Various
01.1982 - 02.2005
- ASQ Pharmaceutical GMP Professional
- ASQ Risk Management Certification
Bachelor of Science - Electrical Engineering
Brigham Young University
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