Sr. Supplier Quality Engineer

PURPOSE AND SCOPE:

The incumbent will be responsible for assisting in the development and execution Supplier Quality Assurance program to include Supplier Audits and Supplier Corrective Action (SCAR). The position will perform supplier audits as required as well as support the development of Supplier Quality programs and processes designed to improve supplier performance and productivity.  In addition, this position will support other quality system processes, as required.

Responsibilities:

• Assess supplier compliance with the Quality System Regulations based on key performance metrics including audits, quality objectives, and complaints
• Assist in the development of Supplier Quality programs and processes designed to improve supplier performance and productivity.
• Assist in the scheduling, planning and performance of Supplier Audits
• Provide consultation as necessary to suppliers regarding investigations and the development and implementation corrective and/or preventive actions. 
• Assist with management of active SCARs through the Corrective Action Board (CAB)
• Assist with the management of active CAPAs when required
• Serve as Quality Administrator for the SCAR system and support the CAPA Quality Administrator role when required.
• Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to reflect supplier audit and SCAR status and monitor trends.
• Assist in the preparation of other Quality System reports when required.
• Support Quality System training as required.
• Support internal audit program as required. Provide consultation as necessary to the internal audited functions regarding investigations and the development and implementation corrective and/or preventive actions when required

Education & Qualifications:

• B.S. in Engineering or Life Science Related Field
• 3 years related quality assurance, quality system experience or an equivalent combination of experience and education. Medical device experience required. Previous quality system audit experience required
• Lead Auditor Certification preferred.
• Advanced knowledge of FDA Quality System Regulation 21 CFR Part 820 as well as ISO13485
• Good organizational, attention to detail and follow-through skills
• Excellent verbal communication and customer interface skills.
• Ability to interface with multiple suppliers and multiple groups within the organization.
• Systems - Basic computer skills – word processing, spreadsheet, windows. MS Office preferred.  Previous experience with Agile a plus
• Willingness to contribute to other departments as necessary
• Ability to travel 30 to 50% of time- domestic and global