Rose Anne Asenjo

Experience

• 

  Ionics-EMS Inc.,

  Nov 2014 - May 2015

  Industrial Engineer

  On-the-Job Training

• 

  ResMed

  Jan 2016 - now

  • Manufacturing Process Implementation: Support process improvements and quality enhancements in the Moulding Factory to support production efficiency and reduce defects.• Process Validation & Compliance: Support IQ, OQ, and PQ validations in alignment with ISO 13485 and ISO 14971 regulations, ensuring compliance in new product introductions.• Process Improvement Initiatives: Support projects focused on optimizing workflows, reducing defects, and increasing manufacturing efficiency.• Data-Driven Decision Making: Utilized statistical analysis and process data to identify inefficiencies and implement corrective actions, improving KPIs.• Cross-Functional Collaboration: Partnered with design and engineering teams to enhance manufacturability of new products, ensuring seamless transition into production. Show less • Leadership & Training: Led a team of Quality Control Inspectors and provided mentorship on technical and compliance requirements.• Process Development & Improvement: Developed and implemented QC methodologies, improving efficiency and standardizing inspection processes across multiple sites.• QMS & Compliance: Acted as Subject Matter Expert (SME) for internal and external audits, ensuring readiness for ISO13485, MDSAP, and regulatory inspections.• Collaboration & Stakeholder Engagement: Worked closely with manufacturing, engineering, and supply chain teams to align quality and production objectives. Show less

  • Quality Assurance Engineer

    Feb 2025 - now

  • Quality Control Team Lead

    Jun 2021 - Feb 2025

  • Quality Control Team Coordinator

    Aug 2018 - Jun 2021

  • Quality Control Inspector

    Jan 2016 - Aug 2018