Overview

The Manager, Quality Assurance 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.

Responsibilities

General Quality- 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

General - 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.

Qualifications

- 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.

Physical Requirements:

• 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.