Manager, Quality Operations Engineering (Medtech)

TL;DR

Manager, Quality Operations Engineering (Medtech): Managing Quality Engineering, Specialist support, key projects, and QA aspects of the Quality Program with an accent on efficient and cost-effective project management. Focus on ensuring compliance with domestic and international requirements (e.g., FDA/ISO/EC/CMDR) and maintaining high standards of customer service.

Location: Onsite in Gainesville, FL

Company

hirify.global focuses on innovation in orthopedic implants and instruments to improve efficacy and outcomes.

What you will do

• Manage Quality Engineering, Specialist support, key projects, and QA related aspects of the Quality Program.
• Ensure compliance with Exactech’s corporate Quality System and meet all domestic and international requirements (e.g., FDA/ISO/EC/CMDR).
• Collaborate with E&D and Manufacturing project teams to ensure accurate and available Quality support.
• Develop, implement, measure, and meet corporate and departmental goals.
• Assist in directing Quality System activities for corrective and prevention actions, internal and third-party audits, and customer complaint coordination.
• Maintain accurate and compliant quality records prior to product release.

Requirements

• Bachelor’s Degree in Science required; Master’s Degree preferred.
• Minimum of 7 years experience, preferably in orthopedic or other medical device field.
• Minimum of 0-5 years prior QA Engineering management experience in a Medical Device Company.
• Experience in inspection specification development, statistical techniques, gage R&R, and G,D&T applications.
• Prior audit experience with FDA and notified bodies.
• Excellent verbal, written communication, and leadership skills.

Culture & Benefits

• Focused on innovation to optimize the surgical experience and improve patient outcomes.
• Committed to using cutting-edge technology to enhance efficacy.
• Aiming to transform the experience of mobility and provide greater freedom for patients.