SpineCraft · 18 hours ago
Associate Quality Engineer - Medical Devices
Westmont, IL
Full-time
Onsite
Entry Level
3+ years expSpineCraft develops, manufactures, and distributes spine surgery implant and instrument systems, and they are seeking an Associate Quality Engineer to ensure compliance with FDA and ISO 13485 regulations. This role involves supporting quality systems, risk management, and process improvements to maintain product safety and efficacy.
MedicalMedical DeviceNeuroscience
Responsibilities
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
Qualification
Required
Bachelor's degree in Mechanical or Biomedical Engineering
3 years in pharma/medical device quality roles (internships count)
Self-motivated individual that is able to work with limited supervision
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
Excellent interpersonal and communication skills
Working knowledge of manufacturing processes and capabilities
Knowledge of FDA QSRs and ISO 13485
Preferred
Working knowledge of manufacturing processes and capabilities
Knowledge of FDA QSRs and ISO 13485
Application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, and Root Cause Analysis advantageous, although not essential
2D & 3D CAD (SolidWorks and/or ProEngineer) experience advantageous, although not essential
Experience with ERP and PLM systems preferred
Benefits
Comprehensive medical, dental, and vision insurance benefits
401K retirement plan
Company
SpineCraft
SpineCraft develops spinal implants designed for revision surgery, deformity correction, degenerative and MIS spine procedures.
11-50 employees
H1B Sponsorship
SpineCraft has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Early StageLeadership Team
Wagdy Asaad
President, CEO and Co-Founder
Recent News
2024-11-30
2024-11-30
Company data provided by crunchbase