Engineer II, Supplier Quality - Shift A
Supplier Quality Engineer II (SQE II) is responsible for delivering all aspects of the Supplier Quality Assurance function. Work in a team environment with suppliers to develop and implement best practices that emphasize defect prevention, reduction in variation and waste, and provide for continuous improvements in meeting all customer requirements. Collect root cause analysis and provide corrective feedback to prevent line stops due to supply issues. Manage the customer specific requirements and offer technical support to suppliers. Responsible for ensuring that the products produced meet quality standards required to minimize quality costs and maximize customer satisfaction whilst ensuring that procedures and processes are adhered to. Job duties:
- Perform analysis and identify trends in the inspection of finished products, in-process materials, and raw materials, and recommend corrective actions when necessary.
- Problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of defects.
- Utilize process improvement tools to drive process and product quality.
- Monitor supplier quality levels and perform development activities with strategic suppliers to ensure quality performance goals are met.
- Perform supplier re-evaluations based on company requirements.
- Initiate action at the RI lab or manufacturing lines to prevent the occurrence of any non‐conformities relating to product, process, and quality systems.
- Maintain approved supplier list updated based on company requirements.
- Perform supplier quality audits.
- Develop projects to improve RI and Release capabilities.
- Development and execution of Test Method validations for RI and Release inspections.
- Development and execution of Software and equipment validations.
- Perform additional duties as assigned.
- Bachelor’s Degree in related field or equivalent.
- Minimum of two (2) years of related experience.
- Strong written and verbal communication skills.
- Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA, 5 WHYs etc.
- 80% English proficiency both written and verbal.
- Medical device industry experience preferred.
- Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 9001, ISO13485, QSR, MDD.
- Understanding and interpretation of engineering drawings.