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Quality Assurance Director
1 month ago
At ACE Partners, we are seeking a highly skilled Quality Assurance Manager to lead our Quality team and ensure compliance with Quality Management Systems and regulatory standards. As a key member of our organization, you will be responsible for managing and maintaining compliance with internal Quality Management Systems and regulatory standards. This includes ensuring organizational awareness of regulatory requirements and quality standards, leading management reviews, reporting on Quality System performance, analyzing metrics, and driving improvements. You will also supervise inspection activities, manage complaint analysis, and corrective/preventive actions. Additionally, you will guide Quality staff and cross-functional teams throughout product development, support risk assessments, process validations, and design changes, and oversee external audits, regulatory certifications, and document control. To be successful in this role, you will need a Bachelor's degree in Science or Engineering with 7+ years in a regulated medical device environment, knowledge of ISO 13485, FDA 21 CFR 820, EU MDR, CAPA, and customer complaints, and experience with Class II/III medical devices and manufacturing process tools (FMEA, Risk Management, Process Validation). Preferred qualifications include Quality certifications (ASQ, Lead Auditor) and strong leadership, audit management, and data-driven decision-making abilities.
