Director Design Assurance

Location:

Ballina or LibertyvilleDepartment:

QualitySummary:The Director of 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 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.Responsibilities:Develop, maintain, and execute strategies to optimize Design Controls, Validation, and Product Lifecycle Risk Management processes and ensure compliance with 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 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.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 related to Validation, Design Assurance & Risk Management to support product launches, matching the skill set of individual direct reports to project demands, prioritizing efforts, anticipating technical issues, and ensuring successful project outcomes.Conduct/Coordinate regular and robust design reviews that assess issues, risks, and resource requirements for all phases of NPI projects.Ensure compliance of product/process/package/label/Test Method/Specification designs and associated documentation with applicable regulations for products distributed globally.Proactively monitor trends linked to the product lifecycle phases to address potential design or quality risks timely.Work closely with the R&D and Global Quality teams to ensure robust new product launch planning and successful design transfer processes.Act as the subject matter expert for Validation, Design Controls, and product lifecycle risk management, representing the company with outside regulatory authorities.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 developing Validation test protocols and study plans, ensuring compliance with all applicable regulatory requirements.Work with R&D to ensure that Product Test Methods are designed to provide appropriate challenges to products and are validated appropriately.Establish a post-launch review process that monitors new product performance against expected market performance and triggers escalation/intervention as necessary.Ensure GMP requirements are well understood across teams regarding validation, Design controls, and Product Lifecycle Risk Management, facilitating education where required.Develop a risk-based approach for decision making and support continuous improvement via cost-efficient processes 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:Extensive knowledge of Medical Devices and/or IVD design and manufacturing, with 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 managing projects in a highly regulated environment.Strong leadership capability and ability to influence change while balancing compliance with pragmatic problem solving.Consistent track record in delivering Continuous Improvement programs.Strong technical ability and effective message delivery.Ability to work and interact with diverse cultures across various time zones.Excellent written and verbal interpersonal skills to influence diverse internal and external stakeholders.Ability to present complex technical information to Senior Management.Work Experience Requirements:12-15 years of overall experience.10+ years 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 uncertainty.Essential experience managing a design assurance team, preferably with remote teams.Education Requirements:Bachelor's Degree in Engineering/Science/Life Sciences; a postgraduate degree in a technical or management discipline is desirable.Specialized Skills and Technical Knowledge:Leadership experience with excellent independent judgment and interpersonal skills.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 from different cultural backgrounds.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 manage deliverables.Good project management skills, including organization and planning.Able to work in a global and matrix environment.Strong critical thinking skills and a focus on achieving overall project goals.Ability to work independently and remotely with minimal 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.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.EOE Statement:All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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