Technical Quality Engineer

Contenido de trabajo

Job DescriptionSUMMARY OF POSITION:The Technical Quality team – APAC ensures effective design-to-commercialization life-cycle quality management activities are in place for all product categories across the end-to-end supply chain so required product quality performance and regulatory compliance is achieved.The Technical Quality Engineer will support activities for one or more product categories &/or platforms including, but not limited to:

• Implementation of QMS elements per global strategic plans
• Support product design changes, product enhancements, material and process changes
• Support Risk management activities
• Investigation of product non-conformances;
• Support the development of processes and systems to improve cost of poor quality
• Ensuring compliance to quality system and product regulatory requirements for the APAC business, manufacturing and distribution facilities and supply base.
• Lead the support of PASS across APAC manufacturing sites

The role requires strong collaboration and influencing skills for successful QMS element implementation, resulting in life-cycle quality management with multiple teams including Research & Engineering, Procurement and Marketing, Global Supply Chain teams such as Global Quality and External ManufacturingThe role reports to Sr Quality Manager - APAC Technical Quality.Essential Accountabilities

• Acquires PASS technical Knowledge from Global PASS deployment leader and Build capabilities in Mill SMEs.
• Understands various defects codes across AFC, BCC and FMC sectors and ensures a standardized approach is applied in the setup for different SKUs across APAC mills.
• Sufficient knowledge and understanding of the PASS system to effectively train and develop SME-s.
• Maintains awareness and oversight of in-market quality and regulatory risks and issues through utilization of PASS data.
• Sets up PASS to support product development and product design change activities.
• Drives PASS use in APAC manufacturing facilities.
• Understands and can apply industry-standard practices concerning relevant QMS elements
• Builds capability and provides coaching and guidance in relation to identified QMS elements as well as PASS
• Ensures APAC QMS standards, processes and practices consistently meet appropriate K-C and external stakeholder requirements for assigned product categories and platforms, for example ISO 9001, 13485 and/or 22716 requirements and specific customer, end-user or regulatory authority expectations.
• Ensures APAC Technical Quality programs, initiatives and targets are appropriate for assigned product categories and platforms to achieve product quality performance and regulatory compliance.
• Maintains awareness of in-market quality and regulatory risks and issues impacting the assigned product categories and platforms
• Supports, and at times, leads the development of goals, targets and outcomes required for new product development and product design changes.
• Adopts a right-first-time quality mindset, including robust problem solving and continual improvement efforts, from initial product and process design to control and on-going monitoring of product quality performance.
• Implements Statistical Problem Analysis/Solving concepts, design transfer, verification and validation activities which enable fact-driven statistically-based decision making as required.
• Ensures risks are proactively identified and mitigated using APAC and K-C risk management tools.
• Key interface and point contact with R&E, Procurement, Manufacturing and Distribution for new product introductions, changes to existing products and throughout the product life cycle to achieve deliverables related to product safety, quality, and performance.
• Is able to communicate effectively with superiors and peers across K-C.
• Is able to influence and engage with cross-functional teams as required, building and maintaining strong relationships and networks.
• Understands and can apply industry-standard practices such as Good Manufacturing / Warehouse Practices (GMP & GWP)
• Builds capability and provides coaching and guidance for quality concepts and tools across cross-functional teams.

Preferred Qualifications

• A Bachelor’s degree in a relevant discipline, typically science or engineering related or significant quality management experience.
• General knowledge of quality management principles and requirements is required. 3-7 years of experience in a Supplier or Manufacturing Quality role or an R&E product role.
• Working knowledge and experience of relevant product performance and other technical or regulatory compliance requirements
• A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Quality Manager / Auditor or CQI Chartered Quality Management Professional.
• Experience of Quality in medical device, cosmetic or similar environment
• Understanding of key regulations and standards applicable to APAC
• Understanding of PASS and ETQ systems

Primary Location Taiwan-TaipeiAdditional Locations China-ShanghaiWorker Type EmployeeWorker Sub-Type RegularTime Type Full time