Description
The Sr. Supplier Quality Engineer (SQE) will support the supplier quality management process and will act as one of the primary contacts with suppliers on all quality related issues during both the supplier maintenance and supplier selection process. This individual will provide support for all supplier management activities, interactions, and continuous improvement initiatives. They provide supplier related support to production and receiving inspection teams and will lead to resolve any non-conformity that is resulted due to supplier performance. The Sr. SQE is in charge of monitoring parts from acquisition through the inspection and manufacturing cycle, and is responsible to communicate and resolve supplier-related process problems as they occur through the MRB process.The Sr. SQE participates in selection of suppliers in the design and development phase as well as the production phase to ensure that the supplier's current and future capabilities will meet the company's needs. This individual develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP's, ISO 13485, and company's quality standards are met. They will act as the Supplier quality representative on Design and Development teams, and ensures that the supplier selection process is followed in accordance to the company guidelines. The Sr. SQE will conduct Supplier Scorecard review to assess suppliers on their ability to meet quality, delivery, and service targets. They also will conduct Supplier audits and ensure supplier implements and maintains any resulting corrective action program, through the SCAR program, and ensure timely closure of SCARs by suppliers.
The Sr. SQE will audit and evaluate suppliers' internal processes to assess their overall compliance to the organization and regulatory requirements, including the monitoring of sub-suppliers, and provides feedback to improve their operation.
Qualifications
A minimum of a Bachelor's degree in a related technical discipline along with a minimum of 5 years of quality engineering experience in the medical device industry is required. Experience with Supplier Quality and Quality System requirements in medical devices industry is required.
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