Supplier Quality Engineering Manager

Posting Date 3 weeks ago(9/2/2022 9:08 AM)
Requisition ID
2022-11410
Job Location(s)
Bloomington IN United States
Travel
20-30%
Position Type
Full Time
Company
Cook Inc - Bloomington
Category
Quality

Overview

The Supplier Quality Engineering Manager at Cook Incorporated serves on a cross functional team, ensuring the adequacy, suitability and compliance of the Quality Management System processes within Supplier Control. Manages day-to-day quality operations and provides leadership and direction to the supplier quality team.

Responsibilities

• Oversees the quality activities related to selecting, developing and maintaining suppliers
• 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
• 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
• 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

Qualifications

• Bachelor's degree in Engineering or Life Science
• Minimum 3 years experience working with quality management system
• Minimum of 5 years experience in a regulated industry, preferably in a medical manufacturing environment
• Supplier, Contract, and Quality Agreement experience highly preferred
• Previous leadership experience, 5 years preferred
• Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects

 

Physical Requirements:

• Works under general office environment conditions

• This position is a hybrid position which requires regular onsite visits, up to 2-3 times per week. Must reside within a reasonable distance, within a two hour radius via car, of Cook Medical in Bloomington, Indiana. 
• 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)

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