Hollister Incorporated | Director Design Assurance | Australia
vor 8 Stunden
Location: Ballina or Libertyville
Department: Quality
Summary:
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.
#J-18808-Ljbffr
-
Central Coast, Österreich Buscojobs VollzeitLocation : BallinaTitle : Administrative AssistantReports to : Vice President OperationsSummary : The Administrative Assistant will provide comprehensive administrative support to the executive leadership team and will be based on site in our manufacturing plant.This role requires exceptional organisational skills, attention to detail, and the ability to...
-
Central Coast, Österreich Tideri Jobbörse VollzeitPress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: We Make Life More Rewarding and DignifiedLocation: BallinaDepartment: Title: Administrative Assistant Reports to: Vice President Operations Summary: The Administrative Assistant will provide comprehensive administrative support to the executive leadership team and...
-
Central Coast, Österreich Tideri Jobbörse VollzeitLocation : Ballina Title : Administrative Assistant Reports to : Vice President Operations Summary : The Administrative Assistant will provide comprehensive administrative support to the executive leadership team and will be based on site in our manufacturing plant.This role requires exceptional organisational skills, attention to detail, and the ability to...
-
Manufacturing Team Lead
vor 2 Monaten
Central Coast, Österreich Hollister Incorporated VollzeitLocation: BallinaDepartment: Ostomy ManufacturingSummary:This is a Team Lead position, working on Weekend Night Shift managing a team of 15-20 Associates.The Manufacturing Team Lead is a key role within the organization tasked with driving daily performance management at the shop floor level.This will be achieved by coaching, guiding and developing hourly...
-
Central Coast, Österreich Buscojobs VollzeitLocation : BallinaTitle : Administrative AssistantReports to : Vice President OperationsSummary :The Administrative Assistant will provide comprehensive administrative support to the executive leadership team and will be based on site in our manufacturing plant.This role requires exceptional organisational skills, attention to detail, and the ability to...
-
Central Coast, Österreich Tideri Jobbörse VollzeitLocation: Ballina Department: Summary: The facilities systems engineer will be responsible for managing and maintaining facilities systems including Trello request system, Calibration management, and Facilities PM's.This will include managing/liaising with contractors, facilities team members, and representatives from other departments.The role will report...
-
Associate Facilities Systems Engineer
vor 2 Monaten
Central Coast, Österreich Hollister Incorporated VollzeitWe Make Life More Rewarding and DignifiedLocation: BallinaDepartment:Summary:The facilities systems engineer will be responsible for managing and maintaining facilities systems including Trello request system, Calibration management and Facilities PM's.This will include managing/liaising with contractors, facilities team members and representatives from...
-
Senior Project Process Engineer
vor 4 Wochen
Central Coast, Österreich Tideri Jobbörse VollzeitPress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: We Make Life More Rewarding and DignifiedLocation: BallinaDepartment: Title: Senior Process Engineer Hierarchical Level: Professional Division/Department: Ostomy, Ballina Number of Direct Reports: None Travel: No Expectation (may increase due to project work) ...
-
Director, Infrastructure Assurance
vor 1 Monat
Central Coast, Österreich Nsw Government VollzeitDirector, Infrastructure Assurance, Ongoing, Sydney We have an exciting opportunity for 2 x ongoing appointments into the Investor Assurance team as Director, Infrastructure Assurance.The Director, Infrastructure Assurance role is at the Senior Executive Band 1 level, with a total remuneration package starting at $217,997 to $242,100 commensurate with...
-
Director, Infrastructure Assurance
vor 1 Monat
Central Coast, Österreich Tideri Jobbörse VollzeitDirector, Infrastructure Assurance, Ongoing, SydneyWe have an exciting opportunity for 2 x ongoing appointments into the Investor Assurance team as Director, Infrastructure Assurance.The Director, Infrastructure Assurance role is at the Senior Executive Band 1 level, with a total remuneration package starting at $217,997 to $242,100 commensurate with...
-
Director, Infrastructure Assurance
vor 1 Monat
Central Coast, Österreich Clearcompany VollzeitDirector, Infrastructure Assurance, Ongoing, Sydney We have an exciting opportunity for 2 x ongoing appointments into the Investor Assurance team as Director, Infrastructure Assurance. The Director, Infrastructure Assurance role is at the Senior Executive Band 1 level, with a total remuneration package starting at $217,997 to $242,100 commensurate with...
-
Manufacturing Controls Engineer
vor 2 Monaten
Central Coast, Österreich Hollister Incorporated VollzeitTitle: Project Process Engineer, ControlsHierarchical Level: ProfessionalDivision/Department: Ostomy, BallinaReports to: Manufacturing Engineering SupervisorNumber of Direct Reports: NoneTravel: 0 to Very Low Expectation (may increase due to project work)Summary:The Controls Engineer will provide automation support for new and existing...
-
Central Coast, Österreich Tideri Jobbörse VollzeitApply now Job no: 564905Work type: Full-timeLocation: Flexible, Geelong - City, Geelong - Waurn Ponds, Melbourne - BurwoodCategories: Management, Legal ServicesFlexible location + hybrid work arrangements Full-time and fixed term for 5 years – Commencing from 24 February 2025 An attractive salary package on offer | 17% Superannuation Team overview: As...
-
El1 Assistant Director Goverance And Assurance
vor 2 Monaten
Central Coast, Österreich Tideri Jobbörse VollzeitThe Governance, Assurance and Secretariat unit works under the Finance and Assurance team of Corporate Group.The unit supports Comcare through: Providing secretariat services for the Audit and Risk Committee, Operations Committee and Performance, Compliance and Engagement Committee.Providing frameworks and support for governance and assurance including...
-
Director Ict Governance And Assurance
vor 3 Wochen
Central Coast, Österreich Tideri Jobbörse VollzeitFull timeAnnualised salary + 15.4% SuperannuationNDIS Quality and Safeguards Commission (NDIS Commission)The NDIS Commission is the dedicated national regulator of NDIS service providers and workers in Australia.The NDIS Commission upholds the rights of NDIS participants to quality and safe supports or services, including those received under the National...
-
Central Coast, Österreich Tideri Jobbörse VollzeitScoresby, Victoria 3179, Australia • Full-time Description Overview of Royal Nut Company: We are a family-owned business, dedicated to sourcing, manufacturing and supplying the highest quality Nuts, Nut Spreads, Dried Fruit, Legumes and Grains, Health Foods, Confectionery, Snack Foods and Spices.Our fascination for delicious flavors, distinctive aromas,...
-
Oilandgas.Org.Uk | Technical Director
Vor 4 Tagen
Central Coast, Österreich Tideri Jobbörse VollzeitJob Description We are AtkinsRéalis, a world-leading design, engineering and project management organisation.We connect people, data and technology to transform the world's infrastructure and energy systems.Together, with our industry partners and clients, and our global team of over 37,000 consultants, designers, engineers and project managers, we can...
-
Manager- Sterility Assurance
vor 2 Wochen
Central Coast, Österreich Csl - Australia VollzeitThe Opportunity:We are looking for a Manager- Sterility Assurance to join our Sterility Assurance team at CSL Behring.In this pivotal role, you will prioritise, organize, and communicate workload and issues/resolutions through appropriate forums and representing topics on local levels.You will work in close collaboration with the local function, most complex...
-
Director, Governance, Assurance And Integrity
vor 1 Monat
Central Coast, Österreich Tideri Jobbörse VollzeitTeam Overview The Governance, Assurance and Integrity team sits within the Corporate Group and is responsible for developing, maintaining and monitoring adherence to policies, frameworks and processes used for governance, risk, fraud control and assurance.Role Overview The Director, Governance, Assurance and Integrity manages a team responsible for...
-
Central Coast, Österreich Tideri Jobbörse VollzeitJLL empowers you to shape a brighter way .Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients.We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they...
