Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Supplier Quality Engineer Job Description Template
Our company is looking for a Supplier Quality Engineer to join our team.
Responsibilities:
- Reporting and overall ownership of Supplier Quality metrics;
- Daily activities at the facility include addressing issues and supporting internal processes such as engineering changes and product approvals;
- Report writing;
- Development of business processes;
- Audit suppliers and work with them to ensure they conform to processes and deliver high quality standards;
- Manage and conduct Pre-Shipment Inspections of goods with far east suppliers to ensure goods meet specifications;
- Work directly with the supplier to facilitate root cause analysis and corrective actions of supplier quality issues;
- Development of suppliers;
- To support final product release of new product throughout the supply-chain;
- To manage and support the supplier complaints process;
- To evaluate, identify and support suppliers zero defect improvement activities;
- Problem resolution (Internal and External);
- To promote and develop the business standard requirements with suppliers;
- Support the Internal Quality team to monitor and report on supplier product quality and performance;
- Organise internal/external measurements necessary to validate the PPAP.
Requirements:
- Working knowledge of the new product design and development in a regulated environment; preferably medical device;
- Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels;
- Excellent written and verbal communication skills;
- Demonstrated knowledge of tools and statistical techniques required to perform thorough root cause analysis and develop strong investigations;
- Demonstrable experience in Quality Engineering and CAPA processes in a medical device or regulated industry;
- Able to understand and analyze complex problems, which may including software and hardware design issues;
- Must be able to travel locally and internationally / full drivers license;
- Strong Project Management skills, including ability to project manage all activities, ability to prioritize and time manage effectively;
- Lead auditor training to ISO13485:2016 (beneficial);
- Bachelor’s degree in engineering or equivalent technical experience;
- Working knowledge of the application of risk management; preferably to medical device development.