Quality Manager – Medical Device Startup, Class II

Job not on LinkedIn

November 6

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🚗 Michigan – Remote

Although this job is listed in Michigan, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Wearlinq

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Healthcare Insurance • Biotechnology • Healthcare

Wearlinq is a pioneering healthcare company specializing in cardiac monitoring solutions, notably through its innovative eWave device. This state-of-the-art, 6-lead wireless cardiac monitor offers remarkable clarity and convenience for both patients and healthcare providers, ensuring continuous and comprehensive heart data collection. With over 33 years of expertise in patient care, Wearlinq focuses on enhancing the patient experience through its user-friendly mobile app and dedicated support services, thereby aiming to elevate the standard of cardiac diagnostics and improve clinical outcomes.

11 - 50 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• 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 • 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 • Develop supplier qualification and monitoring processes appropriate for startup scale • Support process validation and production readiness activities with manufacturing partners • Lead root cause analysis, corrective/preventive actions, and trending • Maintain the risk management file per ISO 14971 throughout the product lifecycle

🎯 Requirements

• 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

🏖️ Benefits

• Health, dental, and vision insurance • Remote work option • Professional growth opportunities as the company scales