Principal Quality Engineer

Is a diagnostic tool truly "innovative" if its Design History File can't survive a Level 3 FDA audit? In the world of In Vitro Diagnostics (IVD), the technical moat isn't just the chemistry or the hardware—it’s the integrity of the design control. One weak link in your Risk Management file can delay a life-critical lab result by months. We are looking for a Principal Quality Engineer to act as the architect of compliance for a high-priority diagnostic pipeline in Marlborough, MA. The Mission: Beyond Checkboxes This isn't a "maintenance" role. You are joining an urgent mission to lead design and development initiatives for products destined for clinical labs. You will: 🔹 Navigate the complexities of IVDR 2017/746 and FDA 21 CFR 820. 🔹 Own the ISO 14971 lifecycle, from initial hazard analysis to post-market surveillance. 🔹 Bridge the gap between R&D and manufacturing to ensure Design Controls are mastered. The Technical Moat We need a specialist who speaks the language of the lab: ✅ 8+ Years of IVD/MedTech Depth: You’ve lived through 510(k), PMA, or De Novo submissions. ✅ Audit-Ready Mentality: You translate complex technical data into regulatory confidence. ✅ IVD Expertise: Direct experience with In Vitro Diagnostics is the primary differentiator for this role. The Vibe & Culture 📍 Location: Marlborough, MA (Hybrid: 3-4 days on-site). ⚡ Energy: A high-impact center where diagnostic breakthroughs happen daily. 🛠 Nature: A 12-month contract designed for a decision-maker, not a cog. The Specifics 💰 Rate: $69.70/hr (Max). 🗓 Shift: Standard 1st Shift (M-F). 🚫 Constraints: US Work Authorization required (No visas). #IVD #QualityEngineering #MedTech #MarlboroughJobs #DesignControls #ISO13485 #IVDR #RegulatoryAffairs