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Manager Global Supplier Quality

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Date: Sep 7, 2022

Location: Libertyville, IL, US

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Libertyville 
Department: Quality 

Summary:

 

Provide leadership and vision for the deployment of a Global Supplier Quality Management System which complies with global regulatory requirements compatible with Hollister’s Mission and Vision. Directly oversees the Global Supplier Quality team, including the Supplier Quality Engineers supporting contract manufacturing, raw material, and service suppliers, in addition to functional oversight of the plant-based Supplier Quality / Incoming QA team.  Hollister Incorporated operates in a hybrid work environment. 

 

Postion can be based out of any of our Hollister locations.

 

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 Supplier Quality Engineers supporting contract manufacturing, raw material, and service suppliers). In addition, provide functional leadership to the plant-based Supplier Quality / Incoming Quality Assurance teams to assure alignment between 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, in-direct 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 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 our New Product Commercialization processes to ensure good supplier/material selection in the development of new products
  • 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 Supplier Quality Engineers supporting contract manufacturing, raw material, and service suppliers). In addition, provide functional leadership to the plant-based Supplier Quality / Incoming Quality Assurance teams to assure alignment between 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, in-direct 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 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 our New Product Commercialization processes 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 achievement of existing quality levels of manufactured products and seek methods to continually improve quality and reduce customer complaints and cost of quality.
  • Provide leadership in change management and risk assessment for process / product changes.
  • Provide input to the Global Quality Management strategic plan as required.
  • Provide direct leadership to the overall plant operations as a member of the Global Contract Manufacturing leadership team.
  • Develop and maintain a plan for the professional development and coaching of all direct reports including supplier quality functions at the plants.
  • 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.
  • Ensure training is provided pertaining to MDSAP good manufacturing practices and quality standards for all associate supporting Supplier Quality activities.
  • 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 associated training profile for position.
  • Other duties and tasks as assigned

 

Requirements:

 

  • 8-12 years overall experience is required
  • Minimum of 4 years in an FDA Regulated industry (8+ is preferred in increasing levels of responsibility)
  • Minimum of 2 years in supervision roles
  • BS in Physical Science, Engineering, or other related discipline
  • ASQ Certified Manager of Quality / Operational Excellence (or equivalent experience) required
  • 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
  • Supervisory experience with excellent independent judgement and interpersonal skills, including oral and written communication.
  • 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.
  • CQA certification (Quality Auditor) or Biomedical Auditor “optional” but desirable
  • 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
  • Ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
  • Strong leadership skills with the ability to influence change cross-functionally and develop people
  • Goal-oriented with the ability to execute on strategic initiatives and prioritize/manage deliverables
  • Good project management skills including organization and planning.
  • Able to work in a global and matrix environment
  • Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
  • Strong critical thinking skills applying and cultivating new approaches to problem solving with a focus on achievement of overall project goals
  • Experience interacting with auditors
  • Ability to work independently and remotely with minimum direct supervision.
  • Greenbelt certification preferred with knowledge of Lean and Six Sigma methodology
  • Knowledge of SAP ERP systems preferred.
  • Strong in Microsoft Office suite, especially Excel.
  • Must be able to read and write English
  • Ability to travel internationally 20% - 30% as needed.

 

#LI-Hybrid

 

 

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 Incorporated is an independent, employee-owned company that develops,manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it 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 (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.  www.Hollister.com 

Hollister is an EO employer – M/F/Veteran/Disability


Job Req ID: 30717


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