Lead Medical Device QA/RA Consultant: ISO 13485 QMS & 510(k) Strategy

Job Description: We are a New England based early-stage medical device startup developing a next generation technology for cardiopulmonary resuscitation. We are currently in development and are looking for an experienced individual consultant to act as our Fractional Quality Manager to help us establish a low-volume, compliant manufacturing facility and assist with our 510(k) documentation effort. The ideal candidate will help us design, implement, and document quality systems and facility controls that support safe, compliant medical device production and regulatory readiness.

This engagement is initially scoped as a consulting / contract role with the potential for ongoing quality leadership support. The Project: We are looking for an alternative to the standard expensive CMO model and intend to manufacture a small number of non-sterile devices in our own (or possibly rented) controlled environment. We need a practical, "lean" compliance strategy that meets FDA and ISO standards without the overhead of the large comprehensive firms. Scope of Work: 1. Facility Selection & Setup (New England Based): • Advise on the requirements for our non-sterile device-build capability.

• Assist in evaluating shared-space facilities to ensure they meet the environmental control requirements for our QMS. • Guidance on state registrations. 2. Lean QMS Implementation (ISO 13485:2016 / 21 CFR 820): • Implement a right-sized Quality Management System tailored for low-volume production, either our own or inside of someone else’s. • Advise and assist us as we author core SOPs: Quality Manual, Document Control, Training, Design Controls, Risk Management (ISO 14971), and Supplier Management.

• Lead us in being audit-ready with respect to the Document Control system. • Serve as Quality Representative and point person for audits, reporting to the CEO 3. 510(k) & Manufacturing Documentation: • Assist in the creation of the Design History File (DHF) and Device Master Record (DMR). • Draft and organize the quality and performance testing sections for our upcoming 510(k) submission. • Advise on Process Validation (IQ/OQ/PQ) requirements for our specific equipment and volume. • Assist in communication with regulatory authorities and notified bodies.

Required

Qualifications: • Proven Track Record: Experiences in Medical Device QA/RA with multiple successful 510(k) clearances. • ISO 13485 Expertise: Deep knowledge of the 2016 standard and the upcoming FDA QMSR transition. • Hands-on experience with low-volume device manufacturing • Local Knowledge: Familiarity with the New England life science ecosystem. • Startup Mindset: You understand how to build a compliant system that is efficient and scalable, not bureaucratic. Project Type: • Duration: 10–24 months (with potential for ongoing maintenance).

• Hours: Part-time/Flexible (approx. 10-15 hours/week on average). • Budget: Please provide your hourly rate or a milestone-based proposal. Apply tot his job Apply tot his job

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