Quality Systems Manager at 4 C Medical Technologies

Description

JOB SUMMARY

 We are seeking a detail-oriented and collaborative Quality System Manager (QMS Manager) to support the design, development, and commercialization of transcatheter mitral heart valve technologies. This role is responsible for ensuring compliance with global regulatory and quality requirements, including FDA QSR, ISO 13485, ISO 5840 and EU MDR. The QMS Manager will be in charge of reviewing, updating, improving, and managing the Quality System throughout the entire process of new product development and ongoing projects. This role is crucial in driving and maintaining ISO 13485 certification and MDR CE marking. As the primary champion of Quality Systems at 4C Medical, the QMS Manager will play a vital role in ensuring the quality and success of our products. 

ESSENTIAL FUNCTIONS

•  Maintain, oversee, and continually improve the Quality Management System in accordance with FDA 21 CFR 820, ISO 13485, ISO 14971, and EU MDR requirements.
• Ensure procedures and processes are properly documented, implemented, and followed throughout the organization.
• Organizes the internal Audit schedule and personally conducts internal audits to assess and improve quality systems compliance.
• Manage the company’s audit readiness and host external regulatory and notified body audits.
• Lead preparation and execution of Management Review meetings in compliance with regulatory expectations.
• Support nonconformance investigations (NCMRs), CAPA activities, and root cause analysis for manufacturing deviations and process issues.
• Support complaint handling, field actions, and post-market surveillance activities.
• Take a structured and methodical problem-solving approach.
• Provide direction, coaching and guidance to extended and core team members.
• Be accountable to complete tasks and objectives.
• Foster a positive culture of growth, collaboration, and achievement across the organization.

Requirements

EDUCATION AND EXPERIENCE

• Minimum of a bachelor’s degree in a technical field or equivalent experience. 
• Must have 8 to 10 years of related professional experience.   
• Experience in quality management, production management, industrial technology or related areas. Considerable experience in working with top management and senior levels of customer's organizations. 
• Experience with Class III medical products would be considered an advantage

KNOWELDGE, SKILLS AND ABILITIES

• Intimate knowledge of ISO 13485, Canadian Medical Device Requirements, CE Marking, EU MDR, FDA Medical Device Regulation (MDR) and FDA requirements.
• Considerable knowledge of manufacturing processes and practices as applicable to the company's products. 
• Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes.
• Strong understanding of industry regulations such as ISO13485 and FDA QSR’s
• Knowledge of statistics, data collection, analysis, and data presentation.
• Knowledge of transcatheter valve technologies would be considered an advantage
• Must have basic (or advanced) computer literacy (Microsoft Office, Excel, Word and Outlook).
• Proficient in technical report writing and review.
• Good communication skills, both oral and written. 
• Possess exceptional organizational skills with the ability to manage multiple priorities.
• Detail oriented and demonstrated ability to remain flexible to meet the Company’s evolving requirements.
• Excellent interpersonal and problem-solving skills.
• Ability to multi-task in a fast-paced work environment necessary to be successful.   
• Ability to work in a team environment across all levels of the organization is essential.   
• Ability to manage subordinates, projects and workflow effectively is a must.  
• Ability to work independently and with minimal direction.
• Ability to define, organize, and manage individual and team tasks.
• Able to travel up to 5%