Quality Systems and Compliance Manager

Be visionary Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

The Quality Systems and Compliance Manager is responsible for developing, implementing, maintaining, and continually improving the Quality Management System (QMS) in accordance with ISO 9001:2015, ISO 13485:2016, applicable regulatory requirements, and EU Medical Device Regulation (MDR) 2017/745. This position provides leadership and oversight for quality assurance, regulatory compliance, risk management, supplier quality management, internal audits, corrective and preventive actions, complaint handling, post-market surveillance activities, and management review processes.

The Quality Assurance Manager ensures products and processes consistently meet customer, statutory, regulatory, and organizational requirements while promoting a culture of quality, continuous improvement, and risk-based decision making. Assignments are complex and strategic in nature, requiring independent judgment, technical expertise, and leadership across cross-functional teams.

include the following, but not limited to:

Establish, implement, maintain, and continuously improve the organization's QMS in compliance with ISO 9001, ISO 13485, EU MDR, applicable national regulations, and company requirements. Serve as management representative or designated quality leader to ensure QMS processes are effectively established, implemented, maintained, and reported to executive management. Monitor QMS performance through quality objectives, KPIs, trend analysis, and management review reporting. Ensure appropriate process interactions, documented information, and quality records are maintained and controlled.

Ensure compliance with applicable medical device regulations including EU MDR 2017/745, FDA Quality System Regulation (as applicable), and other global regulatory requirements. Support regulatory inspections, notified body audits, customer audits, certification audits, and governmental inspections. Ensure quality system procedures support technical documentation, device lifecycle controls, vigilance reporting, and post-market surveillance requirements. Support regulatory submissions and product registrations through quality system compliance activities.

Promote application of risk-based thinking throughout the organization. Ensure quality activities incorporate risk management principles in accordance with ISO 14971 where applicable. Review and monitor quality risks related to products, processes, suppliers, complaints, nonconformities, and field performance. Ensure risk controls remain effective and are periodically evaluated.

Establish and maintain quality plans, inspection strategies, acceptance criteria, validation activities, and process controls. Ensure appropriate verification, validation, qualification, and monitoring activities are performed and documented. Review manufacturing, inspection, testing, and service processes to ensure compliance with established requirements. Support design and development activities by participating in design reviews, verification, validation, and design transfer activities.

Establish and maintain supplier qualification, monitoring, re-evaluation, and approval programs. Conduct supplier audits and assessments using risk-based methodologies. Ensure supplier quality agreements, change notification requirements, and performance monitoring systems are implemented and maintained. Monitor supplier performance metrics and oversee supplier corrective action activities.

Oversee nonconformance management, root cause investigations, corrective actions, preventive actions, and effectiveness verification activities. Ensure timely resolution of quality issues using appropriate problem-solving methodologies. Identify opportunities for continual improvement using data analysis, trend analysis, risk assessment, Lean principles, and process improvement tools. Monitor effectiveness of quality improvement initiatives and report results to leadership.

Develop and maintain internal audit programs compliant with ISO 9001, ISO 13485, and MDR requirements. Coordinate internal, supplier, customer, and certification audits. Ensure audit findings are investigated, corrected, and effectively closed. Prepare and present management…