reputed company Manager - Medical Device Startup (Class II)

Position reputed company reputed company is hiring! We are a growing medical device startup commercializing an FDA Class II device. We’re seeking a proactive, hands-on reputed company Manager to build, reputed company, and continuously improve our reputed company Management System (QMS). This role is ideal for a reputed company reputed company 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 reputed company 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 reputed company. • Prepare for and reputed company FDA and ISO audits once reputed company moves toward commercialization. Design & Development Support • Partner closely with R&D to reputed company reputed company 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 reputed company • reputed company supplier qualification and monitoring processes appropriate for startup reputed company. • Support process validation and production readiness activities with manufacturing partners. • Ensure inspection and release processes are defined and traceable. CAPA, Nonconformance, and Risk Management • reputed company reputed company 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 reputed company activities reputed company. • Help establish systems for field actions and product improvements. Leadership & Culture • Serve as reputed company’s primary reputed company reputed company and FDA reputed company. • reputed company training and guidance to cross-functional teams on reputed company principles. • Promote a culture of compliance, ownership, and reputed company improvement. Qualifications Education & Experience • Bachelor’s degree in engineering, life sciences, or reputed company technical field (advanced degree preferred). • 5+ years of experience in medical device reputed company 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 reputed company with ability to build processes from the ground up. • Excellent communication, organization, and problem-solving skills. • Comfortable balancing regulatory rigor with startup reputed company. • Strong cross-functional collaboration with R&D, operations, and regulatory teams. Preferred Certifications • Certified reputed company Engineer (CQE) or Certified reputed company Auditor (CQA) a plus. • ISO 13485 reputed company Auditor certification a plus. Compensation & Benefits • Competitive startup compensation (salary + potential equity). • Health, dental, and reputed company insurance. • Remote work reputed company. • reputed company reputed company opportunities as reputed company scales. Apply tot his job Apply To this Job