Systems and Operations QA Lead

Benefits

Additional Information

Job Title: Systems and Operations QA Lead Location: Gateway, Cavite (Onsite) The Systems and Operations QA Lead will be oversee the regulatory and systems requirements of the site, ensuring necessary system/ programs are in place. He/She will also be main QA contact for all concerns related factory operations, excluding inbound related which will be under the Laboratory and Inbound QA Lead. He/she will oversee and provides timely response related to regulatory requirements, management system requirements, consumer and customer complaints, and non-factory team raised concerns. He/she will also work with the B&W PC Quality Manager in ensuring UMS Quality Pillar is implemented and embedded in the factory activities Key Accountabilities 1. People, Culture & Linkage Implements program to ensure Quality Team is trained and properly executing all necessary quality checks based on standards Ensures all relevant personnel are knowledgeable of the Quality Management System Liaises with BU/ BG Quality team, R&D, Procurement, Planning and other groups at the factory Coordinates with relevant regulatory groups for any important updates and actions needed to ensure site is fully complaint to latest standards 2. Quality Systems Management Develops and builds quality protocols aligned with category requirements and protocols HACCP and Quality Plan are available, updated based on established program, effective and made aware to all relevant personnel Ensures internal audit program is in place 3. Operations Manages daily schedule of Quality Engineers, Innovation & Change QA and Systems QA Provides timely disposition on held finished products Coordinates with other factory departments of any operations related concerns and ensure necessary actions are taken Leads analysis and elimination of top quality losses based on QA matrix and high risk sporadic ones Provides response related to consumer and customer complaints and ensures all valid ones are addressed to prevent recurrence Ensure quality KPIs are updated Manages Quality Engineers to ensure manufacturing D incidents are reported and closed on time in Quality One Leads review of Q-EWOs ensuring proper root cause analysis and actions are closed Supports B&W PC Quality Manager in ensuring UMS Quality Pillar is in place. Ensuring process parameters critical to achieve god quality characteristics are set and followed consistently 4. Testing & Measurement Ensures proper method validation is conducted for each test method used in the factory Ensures any device, procedure, change that may affect product quality is fully assessed and validated before implementation QCPs and CCPs are validated and fully aligned with both regulatory and global quality standards 5. Costs Works with Laboratory and Inbound QA lead in ensuring: Annual budget is clear and available No cost overspend versus budget Opportunities to improve spent cost related either to cost of good or bad quality are identified 6. Quality and Consumer Safety Working knowledge on the UL Quality Management System, BRC, ISO 22716, T5Z, and FFZ procedures and protocols, as well as on regulatory related standards such as CATO and PDEA Supports the implementation of UL Quality Management System, BRC, ISO 22716, T5Z, and FFZ protocols to ensure consumer safety and overall quality of the final product manufactured in the site especially for new product innovation and new processes. Conducts verification of site compliance to the UL QMS, HACCP, and Category GMP, CATO through internal audits and quality deep dive activities. Develops site specific standard operating procedures and work instructions that supports the consistent implementation of the UL QMS, Consumer Safety Program and other applicable standards. Identifies digital transformation projects for Quality and executes the same to facilitate continual improvement of the Innovation and Improvement process. 7. Continuous Improvement Understands UMS principles and supports the Quality Pillar. Targets quality, waste, and cost improvement with UMS methodology and collaborating with production on the execution of the defined improvements. Utilizes critical thinking to innovate current processes and deploy improvements. 8. Safety, Health, and Environment Respect and follow all safety, health and environment rules, procedures and protocols related to the operations in the site. Understands the legal responsibility relevant to safety, health and environment as well as its implications to the scope of the job. Conducts Safety Behavioral Observations focusing on Safe / Unsafe Acts and Conditions noted within the site as part of daily routine. Full knowledge of the workplace and hazards within it. Utilize all appropriate safety and environmental procedures for people, processes, materials, products, and equipment relevant to the task. 9. Leadership Uphold the development of a highly effective and strong quality team through robust and effective com