The Manager, Quality Assurance (CMH) serves on a cross functional team, ensuring the adequacy, suitability and compliance of Corporate Quality Management System processes. Manages day-to-day quality operations, executes according to controlled processes, and provides quality expertise and mentorship to their quality team.
- Approve quality documents, analyze improvement of the QMS and other department processes, including reviewing, updating, creating, and implementing SOP’s to support improved processes and compliance.
- Responsible for ensuring that processes needed for the quality management system are documented; reporting to top management on the effectiveness of the process(es) and the need for improvement; promoting the awareness of applicable regulatory and quality management system requirements throughout the organization.
- Provide quality expertise and leadership to management and operational personnel.
- Prepare, communicate and monitor quality plans and metrics to support operations.
- Attend, present and provide data for meetings to including Supplier Monitoring activities, project updates and reviews.
- Participate in hiring, interviewing and on boarding process of new hires.
- Responsible for performance management, annual reviews, and assistance with professional development of direct reports.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements, driving quality throughout the organization.
Third-Party Distributor and Supplier Quality
- Oversee the quality activities related to selecting, monitoring and maintaining TPDs and CMH Suppliers including:
- Responsible for driving quality globally and ensuring TPDs/Suppliers are meeting the quality standards.
- Review, approve, monitor and reporting on quality agreements and changes with suppliers and quality of supplier records to drive supplier quality management.
- Develop TPD and Supplier audit schedules, in accordance with procedural instruction
- Review, assess, and approve TPD risk assessments and changes
- Manage and execute audit activities for TPDs and Suppliers
- Manage and execute Supplier and TPD Corrective Action Requests
- Ability to respond effectively to sensitive inquiries or complaints
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
- Bachelor's degree in Engineering or Life Science; or experience of such kind and amount as to provide a comparable background.
- Minimum of 7 years experience in an FDA-regulated industry, preferably in a medical device manufacturing environment.
- Previous leadership experience, 5 years preferred.
- Experience building/leading project teams that are geographically distributed
- Experience defining a program/project strategy and taking it from concept to delivery
- Proficient in Microsoft Word/Excel/Project/Outlook.
• General office environment Demonstrated Project
• Sits for extended periods
• Requires close visual acuity when working with computers, etc.
• Requires occasional early morning or late evening teleconferences
• International and domestic travel, as required
• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.