Quality Manager - Medical Device Startup; Class II
San Jose, Santa Clara County, California, 95199, USA
Listed on 2026-01-12
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Position Summary
Wear Linq 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.
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.
- Competitive startup compensation (salary + potential equity).
- Health, dental, and vision insurance.
- Remote work option.
- Professional growth opportunities as the company scales.
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