Cook Medical Manager, Supplier Quality and Internal Audit in Bloomington, Indiana
The primary responsibilities of the role is to plan, direct and manage the Supplier Quality and Internal Audit functions for Cook Incorporated.The Supplier Quality and Audit Manager serves on a cross functional team, ensuring the adequacy, suitability and compliance of the Quality Management System processes. Manages day-to-day quality operations and provides leadership and direction to the supplier quality and the audit teams.
General- 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 include project updates and reviews.- Participate in hiring, interviewing and onboarding process of new hires.- Responsible for performance management and annual reviews of direct reports.- Authorization of weekly time sheets, concur, PTO request, department specific documents.- 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.
Supplier Quality- Oversees the quality activities related to selecting, developing and maintaining suppliers including:- Responsible for driving quality globally and ensuring 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.-Manages day-to-day supplier auditing
Internal Audit- Manages day-to-day internal auditing and adherence assessment operations and provides leadership and direction to the functional team.- Leads the maintenance, improvement and execution of the internal audit process.- Manages the implementation, maintenance, improvement and execution of the adherence assessment program.- Reviews and approves auditor qualifications, audit plans, audit reports, internal audit non-conformances, and closure of internal audit non-conformances.
- 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 manufacturing environment.- Minimum 5 years experience working with quality management system.- Previous leadership experience, 5 years preferred.- Proficient in Microsoft Word/Excel/Project/Outlook.
• Works under general office environment conditions• Utilizes close visual acuity for working with computers and equipment• Frequently required to sit, stand, walk, and communicate• Minimal lifting with minimal exertion throughout the workday• Travel 20-30% (domestic and internationally)
Posting Date1 month ago(10/19/2020 5:34 PM)
Job Location(s)Bloomington IN United States
Position TypeFull Time