About the job
The Quality Validation Engineer plays a pivotal role in overseeing the planning, coordination, and management of projects to ensure that product development and production align with both customer expectations and internal quality standards. This role involves leading investigations into customer complaints and collaborating with Supply Chain management to assess and enhance supplier performance.
Key Responsibilities:
- Support the Quality Manager in implementing objectives across the organization in conjunction with various departments to optimize product quality and operational efficiency while minimizing costs.
- Identify and resolve inefficiencies within systems that contribute to elevated quality costs.
- Manage the execution of validations and the creation of comprehensive written protocols.
- Oversee change control activities and ensure compliance with FDA regulations, QSR, ISO standards, and customer requirements during customer complaint investigations and corrective actions.
- Utilize CAPA problem-solving techniques to mitigate internal and external failures, employing sound methodologies such as FMEA, Design of Experiments, Cause and Effect Analysis, Flow Charts, and Statistical Process Control to address issues effectively.
- Analyze statistical data pertaining to assigned tasks to assess the adequacy of current standards and propose improvements in quality, including reviewing inspection methods and sampling plans.
- Evaluate compliance with specifications and operational procedures using relevant information and judgment.
- Develop and review product specifications for accuracy and compliance for existing products.
- Plan and conduct Supplier Quality evaluations through scheduled audits and assessments.
- Engage with suppliers to ensure a clear understanding of specified requirements, ensuring customer needs and objectives are met.
- Facilitate the implementation and management of quality agreements with suppliers.
- Organize and conduct training activities related to quality for internal departments, covering topics such as basic statistics, Design of Experiments, Gauge Repeatability and Reproducibility, and Sample Plan designation.
- Collaborate with customers to ensure mutual understanding of requirements and fulfillment of objectives.
- Assist Quality Managers during customer audits and drive the resolution of any findings or observations resulting from those audits.
