Position Overview:

The Supervisor, Quality Operations plays a critical role in ensuring compliance and quality assurance for medical devices in a highly regulated environment, adhering to ISO 13485 and 21 CFR Part 820 standards. This role supervises incoming inspection and calibration processes, manages emerging field feedback, and oversees quality communications for customer notifications. Serving as the quality representative for service and fleet management, the Supervisor supports the lifecycle of medical devices, field upgrades, audits, and inspections. This role leads a calibration technician and an incoming inspector, ensuring effective execution of quality processes in alignment with regulatory and company requirements.

Essential Job Functions and Responsibilities: Incoming Inspection Managemen Calibration Process Oversight Emerging Field Feedback Management Customer Communications Fleet Management and Device End-of-Life Support Field Upgrades and Consignee Tracking Quality Management System (QMS) Support

Required Qualifications:

Bachelor’s degree in engineering, quality, or a related technical field. Minimum of 3 years of experience in quality engineering or related roles within the medical device industry. Experience in service and support quality engineering preferred. 2+ years in a supervisory capacity preferred. Strong understanding of ISO 13485, 21 CFR Part 820, and related regulatory requirements for medical devices. Experience with non-conformance management, CAPA systems, and recall processes in a regulated environment. Excellent problem-solving skills with a focus on root cause analysis and corrective action implementation. Strong communication skills, with the ability to write clear, concise customer notifications and technical memos. Proficiency in managing device traceability systems and field actions. Ability to work cross-functionally and collaborate effectively with engineering, service, and regulatory teams. Self-motivated individual with a strong attention to detail and ability to manage multiple projects simultaneously. A self-starter, motivated and able to positively motivate others. Focused, target driven with a positive, can-do attitude. Leadership and interpersonal skills to develop and manage good working relationships with direct reports and peers.