at Hollister Incorporated in Libertyville, Illinois, United States
Job Description
We Make Life More Rewarding and Dignified
Location: Libertyville
Department: Quality
Summary:
Provide leadership and vision for the deployment of a sound Quality Management System that complies with global regulatory requirements compatible with Hollister's Mission and Vision. Drives improvements to meet customer expectations at the lowest cost possible. Directly oversees the Global Supplier Quality team, including the Quality Assurance associates in Contract Manufacturing, in addition to functional oversight of the plant-based Supplier Quality / Incoming QA team. This role may be based in the following locations: Libertyville, IL; Ballina, Ireland; or Kaunas, Lithuania.
Hollister Incorporated operates in a hybrid work environment.
Responsibilities:
Develop and evaluate the quality assurance models for Global Supplier Quality (including Contract Manufacturing) and structure on a strategic level and adjust as needed.
Provide direct leadership to the Global Supplier Quality team (including the quality assurance team in the Contract Manufacturing team). In addition, provide functional leadership to the plant-based Supplier Quality / Incoming Quality Assurance teams to ensure alignment between the Global team and Plant-based Supplier Quality / Incoming Quality Assurance.
Management Representative for the virtual Contract Manufacturing Quality Management System.
Develop vision and provide leadership for implementation of quality assurance responsibilities in the global management of direct, indirect, and purchased finished good suppliers (including supplier selection, evaluation, approval, re-evaluation, audit, and performance) as well as tracking of quality performance, complaints management, supplier corrective action process, rejection, and non-conformance reporting and improvement processes.
Collaborate with suppliers to ensure achievement of existing quality levels and seek methods to continually improve quality and reduce customer complaints through the use of SCAR and CAPA processes and by cross-functional teamwork.
Active participation at various corporate-wide and department-specific meetings and functions, including staff meetings, team meetings, BU meetings, and technical / should cost and strategy meetings, representing Supplier Quality Assurance.
Maintain a healthy quality system for the Contract Manufacturing virtual plant while standardizing processes across all facilities.
Engage early in new product commercializationprocesses to ensure good supplier/material selection in the development of new products
Build and reinforce a Culture of Quality in a continuous improvement environment.
Collaborate with the manufacturing/supplier teams to ensure the achievement of existing quality levels of manufactured products and seek methods to continually improve quality and reduce customer complaints.
Provide leadership in change management and risk assessment for process/product changes.
Provide input to the Global Quality Managementstrategic plan.
Provide direct leadership to the overall plant operations as a member of the GCM leadership team.
Develop and maintain a plan for the professional development,coaching and performance management of all direct reports.
Build and deliver effective communications at all levels while displaying active listening skills.
Prepare, periodically review, adhere to, and achieve the annual plan goals.
Advise and participate in IT solutions for quality system improvements for Global Supplier Quality.
Ensure training is provided about MDSAPgood manufacturing practices and quality standards for all associates.
Act as key liaison with all regulatory agencies including FDA, MDSAP, and ISO Notified Bodies.
Direct resources for verifying and releasing finished goods into distribution.
Responsible for achieving competency in all identified skill requirements outlined in the associated training profile for the position.
Other duties and tasks as assigned
Work Experience Requirements:
8-12 years overall experience is required
BS in Physical Science, Engineering, or other related discipline
ASQ Certified Manager of Quality / Operational Excellence (or equivalent experience) required
Minimum of 5 years in an FDA Regulated industry (8+ is preferred in increasing levels of responsibility)
Minimum of 4 years in supervision roles
Experience in supplier quality management, quality assurance, plant quality processes, process validation, non-conformance management, complaint management, design assurance, auditing, team resource management, leading teams
Specialized Skills/Technical Knowledge:
Supervisory experience with excellent independent judgment and interpersonal skills
Project management skills required.
Strong technical writing skills and attention to detail
Strong skills in Supplier Management (evaluation, re-evaluation, controls,... For full info follow application link.
Hollister is an EO employer - M/F/Veteran/Disability
