Description
GENERAL SUMMARY:Provide support for Supplier Quality related activities, including managing the supplier base of 400+ contract manufacturing organization (CMO) & non-CMO suppliers, supplier audit and approval, supplier selection, qualification, corrective actions, new product development activities, and assist in Receiving Inspection operations.
KEY RESPONSIBILITIES:
- Actively participate in supplier selection, audits, improvement and qualification in support of existing and new products.
- Participate on New Product Introductions teams to ensure suppliers meet quality, cost and delivery requirements.
- Monitor, analyze, and drive improvement in supplier performance, including audit findings and SCARs.
- Assist suppliers in developing and executing process validations, statistical sampling plans, inspection methodology, and process control plans.
- Problem solving through classical & experimental design methods.
- Provide hands-on technical support for Receiving Inspection personnel as required.
- Support external supplier audits, ensure compliance to department procedures and policies and drive process improvements and efficiencies in the supplier quality department.
QUALITY SYSTEMS REQUIREMENTS
- 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.
REQUIRED QUALIFICATIONS:
- Bachelor's degree in a technical engineering field plus a minimum of 3 years experience auditing in the quality or medical device field
- ASQ CQA, CQE, Lead Auditor certification to ISO 13485, Six Sigma Green Belt or Black Belt strongly preferred.
- Excellent written and verbal communication skills are essential.
- Requires up to 25% travel (domestic and international)
To find out more about Real please visit www.realstaffing.com