Develop and maintain documents and procedures related to quality standards, risk analysis, lessons learned from product recalls, complaints, scrap, and rework, and retain documented information as evidence.
Create and maintain quality systems documentation, such as quality procedures, and work instructions
Utilize basic quality tools along with problem solving and lean manufacturing techniques in the support of continuous improvement, root cause analysis, CAPA program, promoting lessons learned process
Design and implement audits and control plans for products to ensure product quality targets are met
Monitor all manufacturing processes and assess product quality to determine adequacy, capability and ability to comply with customer specifications and company's specifications
Maintain and monitor quality assurance KPIs and standards
Perform and ensure quality conformance through dimensional checks and metrology for all products (NPD & Regular production)
Perform process scrap analysis and present internal scrap reports
Investigate non-conformances and customer complaints, lead completion of root cause analysis, implement corrective actions, and monitor progress and improvements
Interpret prints and measurement tools (GD&T).
Applies statistical process control (SPC) methods for analysing data to evaluate the current process and process changes. Executes statistical process controls for critical to quality (CTQ) characteristics
Responsible for PPAP document preparation for all new products and if necessary, for existing products due to design/process changes.
Assist suppliers to maintain 100% PPAP compliance for all pre-production and production builds
Supports the final inspection department which may include direct inspection, testing, documentation, and analysis to ensure quality and on-time delivery goals are achieved
Actively participates in the internal audit program to identify quality improvement/failure prevention opportunities, and ensures corrective actions are implemented.
Monitor every manufacturing processes and assess product quality to determine adequacy, capability and ability to comply with customer specifications and company's specifications
Leads and performs activities to reduce the cost of quality (warranty, scrap, and rework) using effective problem-solving methods to collect, analyse, and report data in order to prioritize (FMEA) activities that ensure resolution of repeat issues, using 8D problem solving where appropriate.
About You:
Proficient in 8D Problem solving techniques, FMEA, CAPA, Fishbone Diagram, Root Cause analysis, CTQ, GD&T, SPC
Proficient in PPAP, Control Plan, and Gauge R&R.
Experience in QMS (ISO 9001, ISO 13485)
Excellent communications skills - Verbal & Written
Proficient in Microsoft Suite - Word, Excel, Power point