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, approved supplier listing)
• Quality Assurance (incoming inspection, rejection, non-conformance processes)
• Quality Auditing (external auditing preferred) including MDSAP
• Design Assurance (understanding of design and development process and design controls)
• Basic knowledge of medical device sterilization
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971 standards, and EU MDR regulation
• Team leadership and cross-functional team support
• Greenbelt certification preferred with knowledge of Lean and Six Sigma methodology
• Knowledge of SAP ERP systems is preferred
• Must be proficient in English (written & verbal)
• This role is hybrid, with a minimum of 3 days in the office

#LI-Hybrid

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

Our Total Rewards package in aggregate is above market and includes competitive pay, generous paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, generous retirement savings, and a unique Benefit of Employee Share Ownership Program (BESOP).

Hollister is an EO employer - M/F/Veteran/Disability
Job Req ID: 32828