Design Assurance Senior Manager Industry: Medical Devices Role Summary:
Responsible for implementing and maintaining the effectiveness of the Design Controls systems across Manufacturing plants.
Role Responsibilities and Duties: Develop and execute strategies to optimize Design Controls process and ensure compliance and connectivity to the broader corporate design assurance process requirements. Provide design assurance oversight to all functions operating in the New Product Introduction area. Define clear roles and responsibilities for all functions to ensure effective execution of the design controls process (R&D, RA, PM, Operations, Clinical). Ensure timely communication with VP of QA and Senior Leaders on critical design quality. Manage resources 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 designs and associated documentation comply with applicable Regulations for products distributed globally (US/OUS). Pro-actively monitor Post Market surveillance trends to ensure any potential design issues are addressed as well as developing a closed loop feedback system to the design process. Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process. Design Controls SME and person directly responsible to represent the company with outside Regulatory authorities (FDA, NMPA, Notified Bodies, MoH, WHO) on design quality. Participate in Regulatory Agency inspections and respond to queries related to product design controls, change control and complaints. Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission. Establish and execute design control policies, procedures, processes and principles to ensure robust product designs, appropriate evaluation during development and document change controls compliant with requirements. Collaborate with R&D in the development of Design 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. Work with R&D to ensure successful and cost-effective product scale-up and technology transfer from R&D to commercial manufacture. Establish a post launch review process that monitors new product performance against the expected market performance and triggers escalation/intervention as necessary. Develop design assurance processes, systems, and Staff, delivering a high performing team that supports successful NPI execution across all Sites. Role Requirements: Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast-moving R&D environment. 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. Proven track record in delivering successful NPI programs on budget and on time. 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. Education & Experience: Bachelor's Degree – Engineering/Science/Life Sciences – Post graduate degree desirable. 5 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. Location: Galway
Contract Duration: Fulltime Employment
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