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Quality Engineer, Medical Device NPD; Hybrid, Stock

Job in Pleasanton, Alameda County, California, 94566, USA
Listing for: Calyxo
Full Time position
Listed on 2026-07-17
Job specializations:
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 170000 - 185000 USD Yearly USD 170000.00 185000.00 YEAR
Job Description & How to Apply Below
Position: Staff Quality Engineer, Medical Device NPD (Hybrid, Stock Options)

Calyxo, Inc. in Pleasanton, CA is seeking a Staff Quality Engineer to join our New Product Development team.

You will ensure that Class-II medical devices meet quality standards across concept to commercialization, with emphasis on design controls, risk management, V&V, and regulatory compliance. The role requires deep knowledge of ISO 13485, ISO 14971, IEC 62304 and FDA 21 CFR Part 820, collaboration with R&D, Regulatory Affairs, and Manufacturing, and leadership of quality assurance activities

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