Quality Engineer
Core
Design, implement, and maintain quality assurance protocols for processing materials into finished medical products; guide compliance with safety, quality, and regulatory standards for worldwide distribution.
Role type
Quality Engineer (Medical Device Manufacturing)
Builds
Finished medical products for patients with musculoskeletal disorders
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA and ISO 13485 compliance knowledge, risk assessment, design verification and validation, sterilization and packaging validation, change control, non-conforming material management, data analysis for quality trends
Preferred skills
Advanced degree, proficiency in MS Office, strong analytical and problem-solving skills
Technologies
MS Office, ISO 13485
Responsibilities
Review product and process changes for qualification and validation; perform inspections for incoming materials, components, or finished goods; investigate complaints or audit issues; support Design Control activities; assist in quality system development and procedure writing; ensure compliance with governmental laws and regulations
Seniority
Mid-level, hands-on IC
