This position is responsible for working with suppliers, providing guidance on product and component quality requirements. The supplier quality engineer is responsible for all activities related to supplier evaluation, qualifying components at the supplier’s site, and supplier performance.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Communicating to the potential supplier the selection requirements so that the supplier evaluation process is understood by the supplier.
- Participating in audits at suppliers’ sites, covering quality system and production line capability so that a recommendation can be made on their ability to produce and deliver product. Completing audit reports along with recommendations. Issuing corrective actions requests stemming from findings related to the quality system audit. Working with the supplier to determine root cause and implement actions to address findings. This can also include process or “for cause” audits of suppliers’ production lines and/or quality system to ensure conformity to requirements.
- Gathering and reviewing all documents required for the supplier selection process.
- Participating as a cross-functional team member within design control process to launch new product and/or changes to current product for part qualification at the supplier’s site.
- Conducting design transfer review meetings with the supplier to ensure design requirements are manufacturable and clearly communicated.
- Responsible for implementing controls at the supplier to ensure shipped product meets design specifications. Controls may include execution of process and test method validations, Gage R&R, SPC, DOE , PFMEA, Control Plans, and Work Instructions. Also, outlining and communicating first article inspection requirements to the supplier. Upon receipt of first article inspection data, reviewing the data for adequacy and approving.
- Working within SNCR and SCAR process when nonconformances are identified. This includes working with the supplier to ensure containment of impacted product, correction of product, and implementation of corrective and preventive actions to prevent future occurrences. Quality incident resolution may require site visits to a supplier’s facility to better understand the issue.
- Monitoring supplier performance to ensure effectiveness of supplier SCAR responses.
- Preparing quarterly quality data for supplier’s scorecard evaluation and communication of performance to the supplier and applicable team members.
- Executing, jointly with the supplier, continuous improvement plans when supplier performance has become an issue.
- Providing feedback to team members on status of identified nonconformances and related activities. Meeting with management to assist with escalations and problem resolution.
- Perform other duties as assigned.
- Requires a four-year college degree in an engineering, scientific, or technical discipline.
- Minimum of three years of experience in Quality Engineering.
- Must have proficient computer software skills, i.e. Microsoft Office.
- Certified ISO lead auditor is preferred, but not required.