Woodrow Starnes
Quality Engineer
Phone:
352-292-5037
Email:
Address:
23974 NW 182nd RD
High Springs, Florida 32643
Date of Birth:
December 3rd, 1993
Professional Statement
I am an ambitious biomedical engineering professional with a background in the U.S. Marine Corps and quality management in the medical device industry. My current goal is to deepen my expertise and contribute more significantly to the field. Committed to continuous professional growth and upholding the highest standards in quality and regulatory compliance, I am dedicated to driving advancements in medical technology and mentoring emerging professionals in the industry. I am focused on achieving my Certified Quality Engineer certificate by the end of this year. .
Work Experience
Quality Engineer - NovaBone Products, LLC January 2024-Present
Quality Engineer - Zimmer Biomet May 2023-Nov. 2023
Quality Engineer - Myolyn Aug. 2021 - May 2023
Quality Inspector - Winco mfg. Oct 2020 - Aug. 2021
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Process owner and lead investigator for CAPA and complaints processes.
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Determined event reportability of complaints across multiple international jurisdictions.
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Developed and executed quality plans, including major infrastructure upgrades.
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Led validation activities, adding multiple new manufacturing equipment and cleanrooms, ultimately doubling production capacity.
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Partnered cross-functionally to ensure compliance and improve operational efficiency.
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Spearheaded the development and maintenance of quality documentation, ensuring alignment with project deliverables and adherence to stringent timelines.
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Conducted process capability studies and applied Six Sigma methodologies.
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Organized and structured large datasets, preparing them for detailed statistical analysis and validation processes
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Executed process and equipment validations, contributing to maintaining a risk-based integrated management system and ensuring compliance with internal and external quality standards.
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Updated existing procedures and work instructions to align with new methodologies in ERP software application,
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Developed and delivered comprehensive training sessions to staff members on new procedures and the use of the JDE software, fostering employee confidence and proficiency with the new system.
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Employed advanced statistical methods for data analysis, normality testing, and outlier detection, enhancing data integrity and reliability, pertinent to quality audit and CAPA processes.
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Executed process and equipment validations, contributing to maintaining a risk-based integrated management system and ensuring compliance with internal and external quality standards.
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Liaised with various department heads and subject matter experts to facilitate knowledge transfer.
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Maintained project status and visual dashboard in SmartSheets.
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Organized and structured large datasets, preparing them for detailed statistical analysis and validation processes.
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Served as interim project manager in project manager’s absence, including supervisory duties of one other engineer, presenting updates to upper management in meetings among other duties.
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Played a pivotal role in investigating and documenting an FDA Class II Recall.
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Authored and revised key company documentation including SOPs, work instructions, test reports, inspection protocols and risk management protocols.
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Managed supplier evaluations, audits, continued assessment and inspections.
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Established and managed the company's first production account in FDA WebTrader.
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Developed technical files and other regulatory documentation compliant with international standards and regulations (ISO 13485, ISO 14971, US FDA, Health Canada, Australia TGA, EU MDR).
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Directed the design and construction of testing apparatuses, and developed verification testing methods.
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Maintained company quarantine area and managed nonconforming product disposition.
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Managed equipment calibration and maintenance schedules; performed all internal calibrations and maintenance.
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Company representative throughout various regulatory audits.
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Facilitated meetings necessary for scrum, including scrum planning, scrum review, scrum retroactive, daily scrum and backlog refinement meetings, as well as, any follow-up meetings necessary.
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Implemented 5S systems at all workstations on the production floor and R&D lab.
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Led reorganization project of company warehouse to reorder production flow into a more logical, one-piece flow system that improved production time and freed up significant warehouse space.
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Led root cause analysis investigations for all company corrective and preventive actions (CAPA), as well as, any investigations arising from complaints and/or nonconforming product (NCRs).
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Maintained sprint backlog on a scrum board and burndown chart.
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Served as Scrum Master on the product development team.
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Demonstrated meticulous attention to detail and accuracy in quality inspection.
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Utilized knowledge of Geometric Dimensioning and Tolerancing (GD&T) and various measuring equipment to conduct inspections at all stages of production from incoming raw materials to final assembly.