Associate Quality Engineer - Medical Devices

Overview

Spine Craft develops, manufactures and distributes spine surgery implant & instrument systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.

We are looking for an Associate Quality Engineer to join our growing team in Westmont, IL.

The Associate Quality Engineer ensures compliance with FDA, ISO 13485, and other regulatory requirements by supporting quality systems, risk management, and process improvements. This role is critical in maintaining product safety and efficacy through documentation review, non-conformance investigations, and validation support.

• Review records, DHRs (Device History Records), and quality documentation.
• Assist in maintaining CAPA, deviations, and non-conformance reports (NCRs).
• Participate in the review, update, and implementation of procedures affecting quality assurance.
• Help develop, qualify, and validate methods of inspection, testing, and evaluation.
• Help establish internal and external inspection requirements and act as a liaison between R&D department and Quality Control department. Review, approve, and implement inspection plans.
• Participate in FMEAs (Failure Mode Effects Analysis) and root-cause investigations.
• Participate in risk analysis activities per ISO 14971 at different phases of products development, production, and commercialization
• Collaborate with Manufacturing/R&D to validate processes (IQ/OQ/PQ) and product design.
• Prepare quality metrics and assist with analyzing them to recommend improvements.
• Participate in analyzing customers complaints to determine root cause.
• Participate in the on-going evaluation of contract-manufacturers/suppliers.
• Work with contract-manufacturers/suppliers to establish & manage required gages.
• Participate in conducting suppliers’ audits as required.

• Education:
  
  Bachelor’s degree in Mechanical or Biomedical Engineering
• Experience:
  
  3 years in pharma/medical device quality roles (internships count).
• Should be a self-motivated individual that is able to work with limited supervision and must be positive, energetic team player, and an advocate for product excellence and quality.
• Ability to effectively work cross-functionally with Product Development, Operations and Marketing
• Excellent problem solving and troubleshooting skills and excellent interpersonal and communication skills.
• Working knowledge of manufacturing processes and capabilities and knowledge of FDA QSRs and ISO 13485 preferred.
• A pplication of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, and Root Cause Analysis advantageous, although not essential.
• 2D & 3D CAD (Solid Works and/or Pro Engineer) experience advantageous, although not essential.
• Experience with ERP and PLM systems preferred.

Spine Craft offers a generous compensation and benefits package that includes comprehensive medical, dental, and vision insurance benefits plus 401K retirement plan.

Salary commensurate with experience.

Spine Craft is an Equal Opportunity Employer.