Summer Feng

• Implemented continuous improvement initiatives to optimize the validation process, thereby enhancing product quality and reducing costs.
  
• Documented the entire validation process, detailing completed changes or adjustments.
• Ensured compliance with FDA guidelines through thorough validation and accurate documentation.
• Developed validation protocols for systems to ensure compliance with internal policies and external safety requirements.
• Managed multiple validation projects simultaneously, adhering strictly to deadlines and budget constraints.
• Led risk assessment meetings, providing insights on system impact, component criticality, and data integrity.
• Trained and assisted staff in mastering validation techniques, methodologies, and testing processes.
• Developed and delivered training programs for operators to enhance their understanding of validation procedures.
• Analyzed pre-release software titles for compliance with User Requirement Specifications (URS) and reported any defects to relevant parties.
• Reduced operational risks associated with validation systems through regular inspections and targeted revalidation.
• Reduced operational risks associated with validation systems through regular inspections and targeted revalidation.
• Supported new product introductions by validating equipment, processes, software, and cleaning procedures.
• Developed validation plans for projects, setting specific timelines to achieve development and delivery goals.
• Explained complex information in language that is easily understandable by non-technical personnel.
• Contributed to data-driven decision-making in validation processes using statistical tools such as Six Sigma methods.
• Collaborated with cross-functional teams to identify and resolve validation issues.
• Developed validation master plans, process flow diagrams, and standard operating procedures.
• Adhered to tight deadlines to meet customer demands and project timelines.
• Trained and guided onsite and offshore team members in adhering to quality assurance standards, policies, and procedures.

2017–2019 - Assistant Specialist

• Handled administrative and general affairs for production lines.
• Managed supervisor briefings.
• Conducted DHR (Device History Record) reviews and implemented error rate reduction improvements.

2020–2021 - Administrative Specialist

• Managed administrative and general affairs for production lines.
• Scheduled fixture calibrations.
• Achieved the annual 6S Award as a CI Lean Champion.
• Led project Value Stream Mapping (VSM) and CI (Continuous Improvement) Kaizen presentations.
• Managed supervisor briefings.
• Conducted DHR reviews and implemented error rate reduction improvements.

2022 - Administrative Specialist

• Handled administrative and general affairs for production lines.
• Scheduled fixture calibrations.
• Assisted in CI (Continuous Improvement) efforts.
• Conducted DHR reviews and implemented error rate reduction improvements.

• Business quotation and order negotiation
• Procurement inquiries
• CAD drafting
• Performance reporting
• Office maintenance
• Marketing material production
• Exceeded quarterly sales targets consistently by implementing innovative sales strategies and techniques.

• Handling domestic and international anomalies
• Improving machine environments to reduce anomalies
• Business technical support
• Grease experimentation and measurement
• Participation in product hardware development
• Maintained high-quality standards through regular audits of laboratory equipment and adherence to industry regulations.