Director, Design Assurance

We Make Life More Rewarding and Dignified Location: Libertyville Department: Quality Summary: The Director, Design Assurance is responsible for implementing and maintaining the effectiveness of Validation (i.e. Product, Process, Equipment, Software, Test Method, Utilities), Design Controls and Product Lifecycle Risk Management processes throughout the company ensuring that there is a systematic application of policies, procedures, and practices. As a member of the Global Quality & Regulatory Affairs Senior Leadership team this role represents the Global Quality & Regulatory Affairs organization in activities related to product changes and New Product Introductions ensuring ongoing oversight and communication to the organization broadly. Hollister Incorporated operates in a hybrid work environment. This position can be located in Libertvyille, IL or Ballina, Ireland. Responsibilities: Develop, maintain and execute strategies to optimize Design Controls, Validation and Product Lifecycle Risk Management processes and ensure compliance and connectivity to the broader corporate requirements. Directly responsible for the effective organization, administration, training, and supervision of all aspects of Design Assurance, Validation & Risk Management ensuring oversight, cross functional collaboration and best practices employed during product changes and new product introductions. Define clear roles and responsibilities for all functions to ensure effective execution of validation, design controls and product lifecycle risk management processes (R&D, Regulatory Affairs, Project Management Office, Operations, Clinical, Quality, Global Marketing, Global Engineering). Ensure timely communication with key stakeholders including the VP of Global Quality and Senior Leaders on critical validation, design quality and risk management activities. Manage resources as they relate to Validation, Design Assurance & Risk Management to support product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes. Conduct/Coordinate regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects. Ensure that product/process/package/label/Test Method/Specification designs and associated documentation comply with applicable Regulations for products distributed globally (US/OUS). Pro-actively monitor trends linked to the product lifecycle phases (Development, design, production, distribution, postproduction) to ensure any potential design or quality risks are addressed in as timely a manner as possible. Work closely with the R&D and Global Quality teams to ensure robust new product launch planning and successful design transfer process. Validation, Design Controls and product lifecycle risk management SME and person directly responsible to represent the company with outside Regulatory authorities (FDA, NMPA, Notified Bodies, MoH, WHO) on design quality and Regulatory Agency inspections. Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission. Collaborate with R&D, Engineering, Quality & Operations in the development of Validation test protocols and study plans and ensure both test plans and reports are compliant with all applicable regulatory requirements. Work with R&D to ensure that Product Test Methods are designed to provide the appropriate challenge to products and validated appropriately. Establish a post launch review process that monitors new product performance against the expected market performance and triggers escalation/intervention as necessary. Ensure that GMP requirements are well understood across teams as it relates to validation, Design controls and Product Lifecycle Risk Management, facilitate education where required. Develop a risk-based approach for decision making and support continuous improvement via development of cost-efficient processes at sites, and collaboration between sites to optimize global processes and share best practices. Advance local and global initiatives on continuous improvement and strategic initiatives in areas of responsibility. Other duties as assigned. Essential Functions of the Role: Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast-moving R&D environment. Extensive knowledge of Design Controls and Product Lifecycle Risk Management for medical devices. Proven track record of results managing projects in a highly regulated environment. Strong Leadership capability and ability to influence change balancing compliance with pragmatic problem solving. Consistent track record in delivering Continuous Improvement programs. Must have strong technical ability and be articulate in message delivery. Ability to work and interact with several cultures across various time zones. Excellent written and verbal interpersonal skills to influence many diverse internal and external stakeholders. Ability to present complex technical information to Senior Management. Requirements: Bachelor's Degree - Engineering/Science/Life Sciences - Post graduate degree desirable in either a technical or management discipline. 12-15 overall years' experience is required. 10 years plus experience in a QA/R&D or other technical leadership role in a regulated environment. Experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainty. Experience managing a design assurance team is essential and preferably experience working with teams remotely. Specialized Skills/Technical Knowledge: Leadership experience with excellent independent judgement and interpersonal skills, including oral and written communication. Strong technical writing skills and attention to detail 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 Strong critical thinking skills applying and cultivating new approaches to problem solving with a focus on achievement of overall project goals 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. 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). 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. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 33694 Job Segment: Compliance, Regulatory Affairs, Testing, Risk Management, Law, Legal, Technology, Finance