Sr. Supply Quality Engineer

Department: Quality

Location: Gainesville, FL

Description

A Supplier Quality Engineer works with internal customers in support of supplier selection, approval, auditing, and monitoring. Also serves as liaison between suppliers and internal customers to drive supplier quality improvement. Provides technical support for activities associated with supplier assessments, change notifications, and supplier corrective actions. Responsible for implementing quality related-programs and projects. A high degree of SQM professionalism, knowledge, creativity, and flexibility is required.

Key Responsibilities

• Knowledgeable in FDA 21CFR Part 820 regulations and ISO-13485.
• Must adequately represent Advita and Advita QA processes while helping to build Advita-supplier cross functional partnerships.
• Assumes an active role by facilitating selection, development, qualification, approval and monitoring of suppliers
• Leads as supplier liaison with internal customers to ensure effective problem resolution of supplier quality issues
• Lead supplier audits, supplier visits, and coordinates / leads supplier conference calls
• Lead or participate in development or continuous improvement projects focused on supplier quality
• Identify supplier non-conformance (NPR) trends, provide technical support on NPR investigations, follow-up on associated actions, and work cross-functionally to establish relevant inspection and test procedures
• Actively involved with Purchasing and QA on tracking quality performance of product and service suppliers
• Actively involved in establishing Quality Agreements and/or Advita-Supplier Terms & Conditions (T&Cs) in collaboration with suppliers
• Lead justification and rationale for supplier-based Deviation Requests for process and product deviations
• Actively involved in Supplier CAPAs
• Actively involved in First Article Inspection (FAI) program, including establishing requirements, facilitating completion of associated activities, and review and approval of FAI results
• Actively involved in the development of metrics, reports, and management review presentations (as needed)
• Able to support verification and validation activities through IQ, OQ, and PQ protocol development and execution.
• Actively involved in gathering, monitoring, and reporting of Supplier related CAPA triggers
• Assist and support other team members as necessary.
  
  

Skills Knowledge And Expertise

Education:

• Bachelor’s Degree from an accredited institution required; Master’s Degree preferred
  
  

Experience:

• Minimum 5 years of experience in Supplier Quality Management and the medical device industry or other regulated industry
• Must have ISO 13485 Lead Auditor Certification or be able to complete this certification within a year.
• Strong working knowledge of quality systems and risk management (ISO 13485, ISO 17025, ISO 14971, 21 CFR Part 820, Part 11)
• Demonstrated ability to understand technical drawings and Geometric Dimensioning and Tolerancing (GD&T)
• Working knowledge of process and product validation (IQ, OQ, PQ)
• Demonstrated understanding of Failure Mode and Effects Analysis (Design & Process)
  
  

Functional/Technical Knowledge, Skills and Abilities Required:

• Demonstrated understanding of Statistical Techniques, including Statistical Process Control (SPC) and experience implementing SPC or similar controls
• Approximately 25% travel, primarily for supplier audits. Travel may include domestic and international locations, depending on supplier site locations and audit schedules.
• Ability to work effectively in a team environment