Sr. Supply Quality Engineer

Advita Ortho•Gainesville, FL

12h•Onsite

About The Position

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.

Requirements

Bachelor’s Degree from an accredited institution required
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)
Demonstrated understanding of Statistical Techniques, including Statistical Process Control (SPC) and experience implementing SPC or similar controls
Ability to work effectively in a team environment

Nice To Haves

Master’s Degree preferred

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.