Senior Manager, Corporate Auditing and Supplier Quality

Posting Date 3 weeks ago(9/8/2020 8:22 AM)
Requisition ID
2020-7832
Job Location(s)
Bloomington IN United States
Travel
10-20%
Position Type
Full Time
Company
Cook Medical Holdings
Category
Quality

Overview

The Corporate Auditing and Supplier Quality Manager role at Cook Medical will have a responsibility for internal auditing and supplier management within the Cook Medical Management System (CMMS), as well as serve as a global process owner and subject matter expert globally for corporate auditing and supplier quality. This individual will assess the adequacy, sustainability, and compliance of the CMMS. This individual will also be responsible for all aspects of Corporate Supplier Quality Assurance functions on an on-going basis in line with the CMMS Quality Management System and Quality Policy to ensure that raw materials, products and services are fit for purpose and meet customer expectations.

Responsibilities

Oversees corporate auditing activities including:
• Coordinate and manage corporate and global audit processes, tools, training, and data
• Manage and perform compliance audits of the Cook Medical Management System (CMMS) to assess compliance to international governing legislation and applicable standards, and assess adherence to internal requirements
• Assist with third party inspections
• Participate in the development and training of corporate and global audit resources
• Build relationships with management in order to communicate and understand areas of concern

Oversees corporate supplier quality activities including:
• Coordinate and manage corporate and global supplier quality processes, tools, training, and data
• Contribute to and drive the creation and implementation of best practice for supplier quality strategies and processes, analyze improvement of the CMMS QMS including reviewing, updating, creating, and implementing SOP’s to support improved processes and compliance
• Responsible for ensuring that processes needed for the corporate supplier quality management system are documented; reporting to top management on the effectiveness of process(es) and the need for improvement; promoting awareness of applicable regulatory and quality management system requirements throughout the organization
• Responsible for driving supplier quality initiatives globally and ensuring suppliers are meeting quality standards and requirements
• Responsible for establishing and maintaining a corporate supplier quality audit program, a corporate approved supplier list (ASL) and a corporate supplier on-boarding process
• Responsible for establishing, implementing and monitoring corporate and global supplier quality metrics
• Review, approve, monitor and reporting on quality agreements and changes with suppliers and quality of supplier records to drive supplier quality management
• Facilitate deployment of corporate supplier metrics across supply base
• Develop Supplier Engagement Schedules in conjunction with procurement strategies, product group, and mfg. operations requirements. Perform on-site assessments and annual re-qualifications per defined schedules as defined by Global Supplier Quality policies
• Act as a liaison between Procurement and Product group leadership to support supplier warranty and quality initiatives including cost recovery
• Develop supplier quality road-maps leading to improved supplier performance metrics
• Attend, present and provide data for meetings to include supplier performance updates and reviews
• Support all COOK entities in site specific supplier quality issues and drive corrective actions with suppliers
• Responsible for performance management and annual reviews of direct reports
• Facilitate the application of problem solving techniques in all supplier quality aspects
• Contribute to new business initiatives and projects and review and communicate the impact on Supplier Quality activities
• Work with Engineering (Design and Manufacturing) teams to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements

Qualifications

• Bachelor's degree in Engineering or Life Science

• Minimum10 years experience working with quality management systems
• Minimum of 8 years experience in a regulated industry, preferably in a medical manufacturing environment
• Supplier, Contract, and Quality Agreement experience highly preferred
• Previous leadership experience, 10 years preferred.
• Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects and other ERP systems

 

Physical Requirements:

• 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 30-40% (domestic and internationally)

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