Senior Quality Systems Manager

Get AI-powered advice on this job and more exclusive features. Michael Page provided pay range This range is provided by Michael Page. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $150,000.00/yr - $165,000.00/yr The Senior Quality Systems Manager will oversee all aspects of the company's Quality Systems, including compliance, audits, product release, and continuous improvement initiatives in alignment with FDA, ISO, and global regulations. This role also leads and develops the quality team while partnering cross-functionally to support operations, engineering, and overall business objectives. Our client is a global medical device manufacturer focused on delivering high-quality products that improve patient outcomes. They operate in a highly regulated environment and are committed to innovation, compliance, and continuous improvement across their operations Description Lead and manage Quality Systems, ensuring compliance with regulatory and ISO requirements. Oversee internal and external audits, FDA/Notified Body inspections, and related readiness activities. Drive quality system and process improvement initiatives across the organization. Manage and develop the Quality Systems team, including coaching, training, and performance management. Analyze KPIs and quality metrics, recommending and implementing corrective/preventive actions. Provide training on quality regulations and systems to internal stakeholders. Profile Bachelor's degree preferred. Prior experience in a regulated medical device manufacturing environment. Strong knowledge of quality regulations and standards, including ISO 13485, FDA QSR, EU MDR, and related international standards. Experience in audits, CAPA, and validation processes. Strong analytical, problem-solving, and communication skills. Ability to thrive in a fast-paced, dynamic environment with multiple projects. Job Offer 401k MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Seniority level Mid-Senior level Employment type Full-time Job function Management, Manufacturing, and Quality Assurance Industries Manufacturing, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr