Own all

U.S. FDA

quality and regulatory activities for cleared devices High-impact autonomous role with global medical device exposure About Our Client Our client is an innovative medical technology company leveraging advanced manufacturing and engineering capabilities to develop highly specialized healthcare solutions. Backed by strong technical expertise and global resources, the organization is focused on delivering cutting-edge products that improve patient outcomes and advance personalized healthcare. Job Description Quality Management Systems Support and maintain an ISO 13485-compliant Quality Management System while ensuring adherence to FDA Quality Management System Regulations. Develop and manage supplier quality agreements, defining responsibilities, change control procedures, and regulatory requirements. Serve as the primary liaison for FDA communications, inspections, audits, observations, and remediation activities. Lead post-market quality programs including complaint investigations, trend analysis, and adverse event reporting. Conduct internal audits and drive continuous improvement initiatives across quality systems. Product Development & Regulatory Oversight Partner with engineering and manufacturing teams throughout design transfer and commercialization activities. Review and approve quality documentation including DHFs, DMRs, and DHRs. Evaluate design changes and determine potential regulatory impact, including 510(k) submission requirements. Participate in risk assessments and design reviews to ensure product compliance. Supplier Quality & Product Release Review manufacturing records, inspection data, and product documentation prior to commercial release. Establish and improve incoming inspection and verification processes. Qualify, audit, and monitor supplier performance across quality, delivery, and regulatory metrics. Collaborate with suppliers to resolve quality issues and implement corrective actions. Training & Continuous Improvement Deliver quality and regulatory training programs for internal stakeholders. Remain current on evolving FDA, ISO, and medical device regulatory requirements. Support a culture of quality excellence and continuous improvement throughout the organization. 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. 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. The Successful Applicant 1-2+ years of experience in Quality Systems Engineering within implantable medical devices. Strong working knowledge of

FDA 21 CFR

Part 820, ISO 13485, and medical device regulatory requirements. Experience supporting FDA inspections, audit preparedness, 483 responses, and quality remediation efforts. Knowledge of

ISO 14971

risk management and MDSAP requirements. Experience performing root cause investigations, statistical analysis, and CAPA activities. Strong understanding of supplier quality management and auditing processes. Excellent communication and stakeholder management skills. Ability to work independently in a highly visible, hands-on role. CQE or related quality certification preferred. Willingness to travel as needed. What's on Offer Opportunity to own the entire U.S. quality and regulatory function. Direct interaction with FDA and regulatory authorities. Work with innovative medical device technology that positively impacts patient outcomes. High level of autonomy and influence within a growing organization. Exposure to global manufacturing, supplier quality, and regulatory operations.