Quality Assurance Manager

Quality Assurance Manager (Mid-Senior Level) LifeSprout is a science-driven, mission-focused medical device company developing next-generation aesthetic and reconstructive solutions. As we grow and advance our portfolio, quality is at the core of how we design, manufacture, and deliver safe and effective products. We are looking for a Quality Assurance Manager who shares our commitment to excellence, continuous improvement, and a collaborative, “hands‑on” approach to problem‑solving. Position Summary The Quality Assurance Manager is responsible for supporting all Quality Assurance and Quality Systems activities at the Baltimore facility. This role ensures that LifeSprout’s medical devices consistently meet internal quality expectations and comply with all applicable regulatory requirements, including FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, CE Mark requirements, and state and local regulations. Key Responsibilities Lead the management, maintenance, and continuous improvement of the company’s QMS in compliance with ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and other applicable standards. Lead core Quality System processes including but not limited to Corrective and Preventive Actions (CAPA), Deviations, Nonconformances, Document and Record Control, Training Management, Complaint Handling and Post‑Market Surveillance, Change Control, Internal Audit, and Supplier Quality Program. Support internal and external audits, including regulatory agency inspections (e.g., FDA, Notified Bodies). Ensure timely closure of audit findings and implementation of corrective actions. Partner with R&D to ensure robust implementation of design controls and risk management (ISO 14971) throughout the product lifecycle. Support verification and validation activities, technical file development, and documentation required for EU MDR and global submissions. Provide proactive, solutions‑oriented quality input during development, feasibility, and transfer activities. Support manufacturing quality activities including incoming inspection, in-process checks, batch record review, and product release. Contribute to process validation, equipment qualification, and contamination control strategy as needed. Work cross‑functionally with Manufacturing, R&D, and Supply Chain to resolve issues quickly and effectively in a fast‑moving, onsite environment. Support PMS activities including complaint investigations, vigilance assessment support, trend analysis, and EU MDR PMS/PMCF activities. Oversee supplier qualification, auditing, and performance monitoring. Manage the quality assurance aspects of supplier partnerships and ensure compliance with quality agreements. Lead, mentor, and develop the quality assurance team, fostering a culture of accountability and continuous improvement. Foster a proactive, transparent, and collaborative quality‑first culture across LifeSprout. Champion continuous improvement and operational readiness during times of rapid change. Qualifications Bachelor’s degree in Engineering, Life Sciences, or related field. 5–10+ years of Quality Assurance experience in medical devices, combination products, biologics, or related regulated fields. Hands‑on experience with ISO 13485, FDA QMSR, EU MDR, ISO 14971, and core QMS processes (CAPA, NCR/deviation, document control, training, complaints, audits). Experience supporting regulatory audits and supplier audits. Proven ability to thrive in a fast‑paced onsite environment with changing priorities. Strong communication, collaboration, and problem‑solving skills with a practical, “roll up your sleeves” approach. At least 2 years in a management/supervisory role preferred. Onsite presence at Baltimore, MD facility required with occasional travel (5‑15%). Why LifeSprout Opportunity to make a direct impact on cutting‑edge aesthetic and reconstructive medicine solutions. Highly collaborative team with strong cross‑functional engagement. Environment that values initiative, scientific rigor, and continuous improvement. Competitive compensation, benefits, and professional growth opportunities. Eligibility to work in the U.S. is required. #J-18808-Ljbffr