Quality Assurance

Introduction

We are looking for someone with experience working within the scope of Quality Assurance to join our team!

About the Company

Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.

Here at Turner Medical Inc. dba Intech we give our customers a competitive edge in today's highly specialized design and development of OEM orthopedic and spinal instrumentation. We manufacture world-class instruments to meet our customers' most demanding requirements.

High Employee Deductible Medical Plan - 100% employer paid!

Other deductible plans available with competitive cost share options.

About the Quality Assurance Role

Working as a Quality Assurance at Intech will give you the opportunity to gain experience in the quality process of creating complex spinal and orthopedic instruments that improve the lives of patients around the world! Quality Assurance is a well-rounded position that has touchpoints with all aspects of the Quality System, including, but not limited to document control, record retention, change process, CAPA, continuous improvement, training, complaints, and supplier quality. The position will have direct responsibility for tracking and trending with metric reporting. Management of specific subsystems will be dependent on experience, interest, and availability.

Essential Duties and Responsibilities:

• Supplier Quality support: drive quality compliance with suppliers through the on-boarding process, supply timely scorecards to support continuous improvement and follow through on all non-conformity/deviation issued for reduction of errors.
• Document Control System support: process change notifications, route and publish documents, in addition to review documents as a Subject Matter Experts Qualification Assessment (SME-QA process) or SME for final document approval. Assist in the periodic review of documentation.
• Training Platform support: maintain training requirements for the company. Create, read & understand quizzes, upload training within the eQMS platform, facilitate on-time training completion, assist with new hire orientation and training, align expectations of performance with training requirements, and confirm effectiveness of the training program and make improvements as needed.
• Corrective and Preventive Actions (CAPA): process records supporting true root cause identification and effective measures to correct and prevent the [potential] issue; confirm holistically that the risk was mitigated appropriately.
• Create, update, and manage Quality Metrics as required. Assist with QMS meeting preparations.
• Prepare for and participate in internal and external audits. Support external audits and support preparation efforts for upcoming audits throughout the organization.
• Support Quality Manager as needed and engage associates in QMS activities.

Job Qualifications

• 3 years' experience working within ISO 13485 and 21 CFR Part 820 quality systems, preferred.
• QMS manufacturing and auditing experience.
• Computer literate in various software applications including Microsoft Office. Experience with eTQ a plus.
• Experience managing specific subsystems of the QMS is preferred.
• Ability to communicate effectively in multi-discipline, cross cultural environment, and levels of organization.
• Ability to work in a team environment, as well as autonomously.
• Capable of handling stressful situations.
• Bachelor's degree in science, mathematics, or technical discipline.
• 15 years of equivalent experience can supersede the educational requirements