Design Assurance Senior Manager

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 0r 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