RYAN BARDEER
Bloomington,IL
Summary
High-performing professional with 7 years of experience delivering high impact work in the medical device and biotech industry. Skilled in developing strong internal and external relationships to facilitate the collaborative achievement of organizational goals. Confident in ability to thrive in a fast paced environment and leverage my skills in critical thinking and communication to enable team success. Committed to lifelong learning and going the extra mile to contribute to continuous improvement.
Overview
8
8
years of professional experience
Work History
Manufacturing Quality Assurance Manager
SomaLogic
03.2022 - Current
- Led cross functional teams in executing pFMEAs and process control plans for all manufacturing processes/parts resulting in various process improvements and fewer nonconformances
- Coordinated root cause investigations and implementation of systemic/severe problems via CAPAs
- Implemented supplier quality systems, including material specs., scorecards, questionnaires, and a SCAR process
- Initiated a 5S project to improve packaging and shipping processes leading to an 80% decrease in processing time
- Launched an equipment tracking system to ensure validations and preventive maintenance are executed and recorded
- Orchestrated the validation of various laboratory equipment and processes
- Completed quarterly internal audits of various departments (i.e
- Training, quality control, supply chain etc.).
Senior Quality Assurance Engineer
SomaLogic
10.2021 - 03.2022
- Authored pFMEA and process control plan templates standardizing risk management and production control documentation
- Developed finished goods audit/release process ensuring product conformity including certificate of conformance creation.
- Standardized SomaLogic’s batch record process leading to more efficient and accurate manufacturing records
- Validated insulated shipping solutions enabling customers without access to dry ice to utilize SomaLogic’s assay services lab
- Executed a successful software validation of SomaLogic’s eQMS enabling pursuit of ISO 13485 certification.
Quality Assurance Engineer II
Micro
01.2019 - 10.2021
- Developed and executed validations for equipment and processes contributing to robust and stable production
- Hosted and participated in customer, ISO, and FDA audits which led to recertification and no major findings
- Implemented a risk-based approach for NCRs/CAPAs ensuring high risk NCRs were addressed appropriately
- Led cross functional project team to revalidate and improve poor performing processes
- Collaborated with internal and third party metrology labs and suppliers to resolve non-conformances
- Achieved customer approval for various new production parts via production part approval processes (PPAP).
Quality Assurance Engineer I
Micro
07.2017 - 01.2019
- Conducted thorough root cause analyses resulting in effective corrective and preventative actions
- Updated and approved work instructions, process flow diagrams, process control plans and pFMEAs
- Led process improvement projects for ligating clips and needle production resulting in a 20% reduction in scrap
- Provided quality support for manufacturing across several departments (clips, needles, clean room assembly, etc.).
Quality Engineering Co-op
Zimmer Biomet
05.2016 - 08.2016
- Analyzed trends in customer feedback, scrap, and operator efficiency to identify opportunities for improvement
- Conducted training on the use of measurement equipment ensuring consistent and accurate inspection results
- Oversaw the remediation of nonconformances with castings as reported by downstream customers
- Designed fixtures to aid operators in gaging/inspection of castings.
Education
Master’s in Mechanical Engineering -
Stevens Institute of Technology
Hoboken, NJBachelor’s in Biomedical Engineering -
Stevens Institute of Technology
Hoboken, NJGraduate Certificate in Engineering Management -
Stevens Institute of Technology
Hoboken, NJSkills
- ISO 9001
- ISO 13485
- ISO 15189
- 21 CFR 820
- Lean
- 5S
- DMAIC
- 8D
- Statistical Process Control
- APQP
- PPAP
- Minitab
- Arena
- IFS
- DataMetrics
- Microsoft Office
- Project
- Visio
- OneNote
Timeline
Manufacturing Quality Assurance Manager
SomaLogic
03.2022 - Current
Senior Quality Assurance Engineer
SomaLogic
10.2021 - 03.2022
Quality Assurance Engineer II
Micro
01.2019 - 10.2021
Quality Assurance Engineer I
Micro
07.2017 - 01.2019
Quality Engineering Co-op
Zimmer Biomet
05.2016 - 08.2016
Master’s in Mechanical Engineering -
Stevens Institute of Technology
Bachelor’s in Biomedical Engineering -
Stevens Institute of Technology
Graduate Certificate in Engineering Management -
Stevens Institute of Technology
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