QA Global Design Assurance Manager

CPL

Galway

Responsibilities and Duties. Responsible for implementing and maintaining the effectiveness of the Design Controls system across  Manufacturing plants. Direct the Design Assurance organizations based in our Asia/European manufacturing sites. Develop and execute strategies to optimize Design Controls process and ensure compliance  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  Ensure timely communication with Senior Leaders on critical design quality issues  Manage resources to support product launches,  Conduct regular and robust design reviews  Ensure that documentation comply with applicable Regulations for products distributed globally. Participate in Regulatory Agency inspections  Establish and execute design control policies, procedures, processes  Collaborate with R&D in the development of Design test protocols  Work with R&D to ensure successful and cost-effective product scale-up and technology transfer  Develop design assurance processes, systems, and Staff, delivering a high performing team that supports successful NPI execution across all Sites. Requirements. Bachelors Degree Engineering/Science/Life Sciences - Post graduate degree desirable. Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast moving R&D environment. Experience managing a design assurance team is essential and preferably experience working with teams remotely. Proven track record of results managing projects in a highly regulated environment. Strong Leadership capability and ability to influence change. Proven track record in delivering successful NPI programs on budget and on time. Proven track record in delivering Continuous Improvement programs. Must have strong technical ability and be articulate in message delivery. Experience managing in an environment with changing priorities. 5 years plus experience in a QA/R&D 0r other Technical leadership role in a regulated environment. Contact Brenda Flannery on 0858723761 or brenda.flannery@cpl.ie for more details. Stamp 4 Visa Required for this role.   #LI-130690691_BF1.

1257 days ago