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Quality Manager - Medical Device Startup (Class II)

Quality Manager - Medical Device Startup (Class II)

WearLinqSan Jose, California, United States
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WearLinq is hiring! We are a growing medical device startup commercializing an FDA Class II device.We're seeking a proactive, hands-on. Quality Management System (QMS).This role is ideal for a ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Startup line Engineer

Startup line Engineer

Align TechnologySan Jose, CA, US
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Join our Research and Development team as a 3D Printed Medical Device Startup Line Engineer with a focus on manufacturability of medical devices. In this role, you will collaborate with a small team...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Senior Startup Development Manager

Senior Startup Development Manager

VirtualVocationsSanta Clara, California, United States
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A company is looking for a Senior Startup Development Manager.Key Responsibilities Deploy features and services by aligning deployment modules with customers and validating success Monitor data ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Quality Manager - Medical Device Startup (Class II)

Quality Manager - Medical Device Startup (Class II)

WearLinqSan Jose, California, United States
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Position Summary

WearLinq is hiring! We are a growing medical device startup commercializing an FDA Class II device. We're seeking a proactive, hands-on Quality Manager to build, lead, and continuously improve our Quality Management System (QMS). This role is ideal for a quality professional who thrives in a fast-paced, early-stage environment and wants to directly influence product development, regulatory readiness, and company culture.

You will be responsible for maintaining compliance with FDA 21 CFR Part 820 and ISO 14971 , while also supporting design control, supplier qualification, risk management, and post-market processes.

Key Responsibilities

Quality System Development & Compliance

  • Maintain and improve a right-sized QMS tailored to a startup environment while ensuring compliance with FDA requirements.
  • Manage document control, change control, training records, equipment calibration, and supplier quality.
  • Prepare for and lead FDA and ISO audits once the company moves toward commercialization.

Design & Development Support

  • Partner closely with R&D to embed quality into design control activities—design reviews, verification and validation planning, risk management, and design history file maintenance.
  • Ensure design documentation aligns with regulatory expectations for Class II devices.

    • Manufacturing & Supplier Quality

  • Develop supplier qualification and monitoring processes appropriate for startup scale.
  • Support process validation and production readiness activities with manufacturing partners.
  • Ensure inspection and release processes are defined and traceable.

    • CAPA, Nonconformance, and Risk Management

  • Lead root cause analysis, corrective / preventive actions, and trending.
  • Maintain the risk management file per ISO 14971 throughout the product lifecycle.

    • Post-Market Readiness

  • Contribute to complaint handling, vigilance, and post-market surveillance systems as commercial activities begin.
  • Help establish systems for field actions and product improvements.

    • Leadership & Culture

  • Serve as the company's primary quality lead and FDA liaison.
  • Provide training and guidance to cross-functional teams on quality principles.
  • Promote a culture of compliance, ownership, and continuous improvement.

    • Qualifications

    Education & Experience

  • Bachelor's degree in engineering, life sciences, or related technical field (advanced degree preferred).
  • 5+ years of experience in medical device quality assurance; startup or small-company experience strongly preferred.
  • Proven knowledge of FDA 21 CFR Part 820 and ISO 14971 .
  • Hands-on experience with design control , risk management , and process validation for Class II devices.
  • Experience leading or supporting FDA inspections or ISO audits .
  • Familiarity with electronic QMS tools or willingness to implement one.

    • Skills & Attributes

  • Entrepreneurial mindset with ability to build processes from the ground up.
  • Excellent communication, organization, and problem-solving skills.
  • Comfortable balancing regulatory rigor with startup agility.
  • Strong cross-functional collaboration with R&D, operations, and regulatory teams.

    • Preferred Certifications

  • Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) a plus.
  • ISO 13485 Lead Auditor certification a plus.

    • Compensation & Benefits

  • Competitive startup compensation (salary + potential equity).
  • Health, dental, and vision insurance.
  • Remote work option.
  • Professional growth opportunities as the company scales.