Robert King
Round Rock,Texas
Summary
Quality Operations leader with extensive experience in managing quality systems in regulated industries. Proven track record in implementing strategies that enhance operational efficiency, ensure compliance, and improve product quality. Expertise in quality system requirements, audit management, and risk management. Focused on fostering innovation, employee development, and continuous improvement to drive sustainable growth.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Director, Quality Operations
Artivion
Austin, TX
09.2021 - Current
- Lead the Quality Operations team at the Austin facility, including Quality Engineering, Quality Control, Quality Systems, and Supplier Quality Engineering.
- Serve as the Management Representative for the Austin Facility.
- Strategically planned and executed production growth of 111% from 2021-2025, while maintaining Quality Standards
- Sit on multiple steering committees, including QMS Global Harmonization, eQMS, and Global Infrastructure Strategy.
- Manage a $7 million budget to ensure that operating and capital expenditures are maintained appropriately.
- Maintained a flawless regulatory compliance record with zero major audit findings in twelve consecutive audits (MDSAP, ISO 13485, EU MDR, OEM, etc.). With no findings related to site responsibilities.
- Hosted a notified body audit during the first days of a cyber event, with no internet or network access, with zero findings.
Associate Director, Quality Engineering
CryoLife
Kennesaw, GA
04.2021 - 09.2021
- Managed team of Engineers responsible for Quality Engineering, Risk Management, Software Quality Engineering, New Product Development, manufacturing transfers, and sustaining product lines.
- Represented Core team for Quality in PerClot PMA device submission, approval received in 2021.
- Led initiatives resulting in quality improvements and a 34% improvement in direct labor productivity through integrating lean methodologies.
- Managed a $3 million budget to ensure operating and capital expenditures are maintained appropriately.
- Collaborated with cross-functional teams to align project goals and resources effectively.
- Analyzed market trends to inform decision-making and strategic planning efforts.
Manager, Quality Engineering
CryoLife
Kennesaw, GA
04.2019 - 04.2021
- Managed a team of engineers responsible for quality engineering, supplier quality, risk management, new product development, manufacturing transfers, and sustaining product lines.
- Redesigned the design controls process as part of the corporate objective.
- Transferred the contract manufacturer of a class III device from a site in California to a site in Indiana.
- Key member of project team that successfully launched class III device, requiring IDE clinical trial, from concept to design transfer.
- Completed EU MDR remediation efforts, including risk management and technical documentation.
- Front room facilitator for regulatory audits.
- Lead internal and supplier auditor.
Supplier Quality Engineer
CryoLife
Kennesaw, GA
03.2017 - 04.2019
- Overhauled the supplier quality program in compliance with 21 CFR 820 and ISO 13485 to drive compliance and efficiency.
- Collaborate with development teams to select appropriate suppliers.
- Develop scorecards and improvement plans for poor performance.
- Conduct supplier audits to mitigate risk to the company.
- Drive the SCAR process in collaboration with suppliers.
Quality Engineer
Sarvint Technologies
Atlanta, GA
04.2016 - 02.2017
- Develop and implement a Quality Management System for a wearable technology start-up.
- Developed and validated test methods for DV&V activities. Performed all testing, from concept through beta.
- Review data, analyze, and report to top management on project status.
- Initiate supplier relationships, and maintain supplier quality.
- Investigate CAPAs, and non-conformances, and determine appropriate dispositions.
- Lead design control and phase reviews for new product development.
- Led project management activities and managed the timeliness of activities for all engineering functions.
Supervisor, QA/QC
CryoLife
Atlanta, GA
01.2014 - 03.2016
- Supervise QA/QC group and assure compliance of HeRO Graft and PerClot product lines.
- Successfully implemented lean initiatives to increase efficiency for Operations and QA/QC groups.
- Key project team member for new product development and change control compliance.
- Assist Quality Manager in preparation and justification of departmental budget.
- Ensure specifications, sampling plans, procedures, and test methods are accurate, valid, and functional.
- Establish and ensure completion of departmental goals.
- Perform final batch record review and final product release to finished goods.
- Ensure programs are in place to evaluate and disposition non-conforming materials/products. Identify causes and ensure appropriate corrective actions are taken to reduce the number of non-conformances.
- Led and implemented Lean Six Sigma project saving ~$50,000 per year.
Coordinator, QA/QC
CryoLife
Atlanta, GA
01.2013 - 01.2014
- Coordinated activities within the QA/QC function.
- Ensured complaint reports were comprehensive, thorough, generated, and reviewed in the required time frame.
- Authored and executed protocols, testing, and final reports for shelf-life studies, and Quality Engineering studies, as needed.
Senior Technician, QA/QC
CryoLife
Kennesaw, GA
01.2011 - 01.2013
- Performed raw material, in-process, and final product testing to ensure compliance with specifications.
- Led manufacturing transfer from Hemosphere to CryoLife after corporate acquisition.
- Completed complaint investigation reports.
- Authored and executed protocols, testing, and final reports for shelf-life studies, and Quality Engineering studies, as needed.
BioAdhesive Production Associate II
CryoLife
Kennesaw, GA
05.2009 - 01.2011
- Performed all manufacturing processes involved in BioGlue, BioFoam, and ProPatch manufacturing.
- Assisted in daily schedule creation.
- Trained new team members on equipment usage and safety protocols.
- Maintained accurate records of production activities and inventory levels.
- Performed routine maintenance on equipment used in the production process.
Education
Bachelors of Science - Biology
The University of Georgia
Athens, GA05.2009
Skills
- Quality Management Systems
- ISO 14971 Risk Management
- Supplier Quality
- Lean Manufacturing & Six Sigma
- Leadership and Strategic Planning
- Budget Management
- KPI & Performance Management
- CAPA / Problem Solving
- Internal and External Audit
- Organization / Team Building
Certification
- ASQ Certified Quality Auditor
- ASQ Certified Quality Engineer
- ASQ Certified Supplier Quality Professional
- Lean Six Sigma Green Belt Certified
Timeline
Director, Quality Operations
Artivion
09.2021 - Current
Associate Director, Quality Engineering
CryoLife
04.2021 - 09.2021
Manager, Quality Engineering
CryoLife
04.2019 - 04.2021
Supplier Quality Engineer
CryoLife
03.2017 - 04.2019
Quality Engineer
Sarvint Technologies
04.2016 - 02.2017
Supervisor, QA/QC
CryoLife
01.2014 - 03.2016
Coordinator, QA/QC
CryoLife
01.2013 - 01.2014
Senior Technician, QA/QC
CryoLife
01.2011 - 01.2013
BioAdhesive Production Associate II
CryoLife
05.2009 - 01.2011
Bachelors of Science - Biology
The University of Georgia
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