Senior Supplier Quality Engineer (Medtech)

TL;DR

Senior Supplier Quality Engineer (Medtech): Managing supplier quality processes, audits, and performance monitoring for orthopedic medical devices with an accent on regulatory compliance and process validation. Focus on driving supplier corrective actions, facilitating FAI programs, and ensuring adherence to ISO 13485 and FDA standards.

Location: Onsite in Gainesville, FL

Company

hirify.global is an innovative medical technology company focused on developing advanced orthopedic implants and surgical instruments to improve patient mobility and outcomes.

What you will do

• Facilitate the selection, qualification, and ongoing monitoring of product and service suppliers.
• Lead supplier audits, site visits, and coordinate cross-functional conference calls for issue resolution.
• Identify and investigate supplier non-conformance trends and manage associated corrective actions (CAPA).
• Collaborate with Purchasing and QA to establish quality agreements and terms and conditions.
• Oversee the First Article Inspection (FAI) program and support IQ, OQ, and PQ validation activities.
• Develop metrics, reports, and management review presentations to track supplier performance.

Requirements

• Bachelor’s degree required; Master’s degree preferred.
• Minimum 5 years of experience in Supplier Quality Management within the medical device or regulated industry.
• Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Ability to interpret technical drawings and Geometric Dimensioning and Tolerancing (GD&T).
• Proficiency in statistical techniques, including Statistical Process Control (SPC).
• Must be able to travel approximately 25% for domestic and international supplier audits.

Nice to have

• ISO 13485 Lead Auditor Certification (or ability to obtain within one year).
• Experience with ISO 17025 and 21 CFR Part 11.

Culture & Benefits

• Focus on innovation and cutting-edge technology in the orthopedic field.
• Collaborative team environment working across functional departments.
• Opportunities to influence quality standards and surgical outcomes.

Hiring process

• Initial interview.
• Hiring manager and team interview(s).
• Final selection and offer.