Senior Quality Engineer, Validation (Medical Devices)

TL;DR

Senior Quality Engineer, Validation (Medical Devices): Providing cross-functional support in V&V development, planning and execution for medical device processes and equipment with an accent on compliance with FDA and ISO regulations. Focus on designing and executing IQ/OQ/PQ protocols, implementing risk-based approaches (FMEA), and managing company-wide validation CAPAs.

Location: Onsite in Gainesville, FL

Company

hirify.global focuses on innovation in orthopedic implants and instruments to optimize the surgical experience and improve patient outcomes.

What you will do

• Provide technical engineering assistance for V&V requirements of medical device processes, materials, and equipment.
• Develop and execute IQ, OQ, PQ, SOPs, and summary reports using a risk-based approach (pFMEA, FMEA).
• Implement and maintain corporate validation auditing programs and track progress via a Validation Project Dashboard.
• Lead the identification and correction of manufacturing deviations and anomalies related to V&V activities.
• Manage company-wide validation-related Corrective and Preventive Actions (CAPA).
• Coordinate with Regulatory Affairs and oversee external supply chain V&V activities.

Requirements

• Bachelor's Degree from an accredited institution.
• Proven experience writing IQ/OQ/PQ V&V protocols.
• Working knowledge of FDA and ISO Regulations and Risk Management principles.
• Statistical expertise in process capability, assurance, and sampling.
• Proficiency in Microsoft Office and technical software.
• Must be based in or able to work onsite in Gainesville, FL.

Nice to have

• Master's Degree.
• ASQ Certifications.
• General understanding of sterilization and related analytical testing.

Culture & Benefits

• Environment focused on cutting-edge technology and surgical innovation.
• Collaborative cross-functional project team structure.
• Opportunity to impact patient mobility and freedom through medical advancement.

Hiring process

• Initial Interview.
• Hiring Manager and Team Interviews.
• Final Selection and Offer.