Job Description
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.
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.
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.
- 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.
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