Experience

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  3m

  Oct 2017 - Feb 2024

  Key Responsibilities and Accountabilities• Global Quality Assurance oversight for $250 MM products, produced at 20+ manufacturing locations.• Provides Design Owner (Division level) Quality Assurance support for globally marketed products and medical device components. • Support activities include change management, customer complaints, risk management, quality improvement and cost reduction projects, and compliance activities. • Drives and delivers proactive customer complaint and continuous improvement efforts. • Leads CAPA, Risk Management, Risk Reviews, Material Review Boards, and change control.• Assesses product changes to determine necessary verification/validation level and stability study requirements.• Develops and analyzes shelf life and stability studies to set and validate product claims.• Direct communication and point of contact for key OEM customers.• Provides feedback and drives improvements with supplier through the SCAR process based on customer complaints, in-coming and in-process nonconforming material.• Drives and fosters a quality environment and mindset throughout the business. Participates in cross-functional teams to deliver product and process improvements.Key Achievements:• Led multiple cross-functional significant customer complaint investigations requiring coordination of corrective actions across various 3M non-healthcare plants virtually to ensure sufficient issue resolution requiring significant project management as well as skilled influential leadership. • Supported 25+ active projects at any given time related to both sustainment engineering and new product introductions.• Coordinated continuous monitoring of 50+ stability studies throughout the year that support new product introduction activities and/or product changes. Typical stability study tasks include regular updates to the cross-functional teams, report writing, and investigation reports for out of specification results. Show less Key Responsibilities and Accountabilities• Quality Assurance oversight for $200 MM products.• Provided Design Owner (Division level) Quality Assurance support for globally marketed medical device components.• Other Responsibilities and Accountabilities see Sr. Quality Engineer above.Key Achievements:• Led cross-functional significant customer complaint investigation for legacy silicone-acrylate double coated tape as a response to three related customer complaints for low adhesion on the silicone side of the double coated tape. Investigation activities included batch tracing, review of production data, retain testing, analytical analysis, and fishbone diagram assessment. Numerous potential root causes were assessed and ruled out; most likely causes were evaluated for corrective and preventative actions. • Achieved 5%+ reduction in number of customer complaints and customer complaint credits in 2021. Complaint reduction activities included a specification change to align with customer responses for poor poly bond within the polyurethane product family, regular meetings with Japan and China teams, and hosted quality crew meetings once per quarter for production crews and supervisors to discuss customer complaints.• Updated several risk management documents for existing products to comply with updated regulations. Show less Key Responsibilities and Accountabilities• Wrote and executed test method and test equipment qualifications and crossovers.• Created protocols and summary reports for Installation, Operation (IQOQ) and Process Qualification (PQ).• Participated in quality systems and process audits.• Collaborated with cross-functional teams to procure new test equipment.• Developed new test methods and executed test method validations and test equipment software validation for new and existing products.• Drove continuous improvement through quality improvement projects within Brookings.Key Achievements:• Completed Lean Six Sigma Green Belt Project to streamline Brookings environmental monitoring data collection to develop formal periodic review, establish alert limits, maintain or reduce number of samples, and enable site growth and maintain a stable environmental monitoring process for a healthcare plant. Tools used include business process redesign, process mapping, and C&E matrix (risk assessment). Project selected as “Best Use of Tools” within the Medical Solutions Division for the quarter.• Completed numerous test equipment scale-up projects which included IQ/OQ/PQ to provide evidence that the equipment is installed and operating properly for intended use, Software and Part 11 Assessment (URS) to determine if the equipment needed to undergo Software or Part 11 Validation, technician training, and design transfer.• Led several test method validations and crossover studies, many of which assisted NPI teams to meet their deadlines. Typical validation/crossover tasks include writing protocols, training technicians, sample creation, data analysis, and report writing. Show less

  • Senior Quality Engineer

    Sept 2022 - Feb 2024

  • Advanced Quality Engineer

    May 2020 - Sept 2022

  • Quality Engineer

    Oct 2017 - May 2020
• 

  Solventum

  Feb 2024 - now

  Senior supplier quality engineer