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Complaints Project Manager & Business Analyst

Job Title: Complaints Project Manager & Business Analyst
Contract Type: Permanent
Location: Galway
REF: 95697
Job Published: 5 months ago

Job Description

Contact: Anne Marie Fox
Telephone: 087 2197421

Complaints Project Manager & Business Analyst

Our client, a medical device company in Galway is currently looking to recruit a Complaints Project Manager & Business Analyst for their site.

Responsibilities and Duties
  • Lead the Project to deploy the Complaints Intake process and the change initiatives to integrate, leverage and implement AQR Policies and Processes
  • Identify, plan and implement the project scope (including changes), ensuing risk, issues, and dependencies are understood, communicated and baselined, whilst any assumptions are verified
  • Utilize the ARDx project management methodology (MAPS), and coaching project team members in its use
  • Create and resource a project team to ensure successful project delivery. Take an active part in steering groups to ensure that project oversight and governance is in place and effective
  • Ensure the project meets the expectations of Quality and Regulatory compliance guidelines and satisfy FDA, ISO, internal and respective market & regulatory requirements
  • Make sure the electronic system is assessed, and plans put in place to maintain its validated state
  • Create a step-change improvement in the operational effectiveness (i.e. procedures, work instructions, etc.) of the Business Unit and centralized hubs by driving the deployment of the project
  • Work with Business Unit and centralized hub leaders to plan the future project roadmap and budgets on a rolling basis. Define new projects and their resource implications; challenging team members to ensure they fit into their priorities
  • Work with the Quality and Regulatory Excellence program leader to report progress against plan, risks, issues, dependencies, overall delivery and financial status
  • Develop a close working relationship with the Business Unit leaders to understand the requirements, and to inform their decision making with respect to the Complaints Intake Process
  • Document requirements, translate requirements into high level complaints management processes and business solutions, verify & validate the solutions, deploy the solution and measure its effectiveness
  • Maintain knowledge of strategic developments within the Business Unit and in the diagnostics / medical devices industry at large ensuring at all times that the project has relevant content to support the strategic and competitive direction of the Business Unit
  • Embed continuous improvement strategies into the project discipline whilst operating a controlled, structured and well managed project
  • Any other duties reasonably requested to meet business objectives

General Responsibilities
  • Pro-active self-starter, with a hands-on, practical approach and the determination, commitment and flexibility to meet the demands of the position
  • Strong customer service orientation, able to understand, manage and meet the project demands, and deliver exceptional service to the Business Unit, complaints intake hubs and colleagues at all times
  • Seen as a role model, as well as a reputable representative for the Complaints Intake team
  • Solid team skills, able to effectively motivate cross functional, virtual teams, and lead or delegate as required to ensure achievement of team and project objectives
  • Proficient communicator in English with excellent written and verbal communication skills, strong influencing and persuasion skills, and ability to instill confidence in others
  • Results oriented mind-set, with excellent analytical skills, methodical and logical approach, and the ability to combine technical knowledge, judgment skills on a pragmatic approach
  • Outstanding time management abilities, diligent and conscientious approach, able to work under pressure, organize and prioritize a busy workload, and adapt to fit the changing needs of the Business Unit
  • Must be diplomatic, persuasive and able to handle difficult conversations with colleagues from varying backgrounds and cultures
  • Carries out duties in compliance with established practices, Policies and Processes
  • Demonstrates commitment to the development, implementation and effectiveness of the Business Unit Quality Management System per ISO, FDA, and other regulatory agencies
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the Complaints Intake team and is consistent with the Complaints Management Policies and Processes
  • Understands and is aware of the quality consequences which may occur from the improper performance of their role

  • Fluent business English speaker
  • Prince2 Practitioner qualification (or equivalent in PMP, IPMA or CAPM)
  • Bachelor’s Degree or equivalent qualification (as a minimum)
  • Experience (i.e. greater than 3 end-to-end projects) of successfully managing Quality & Regulatory projects, with demonstrable evidence of effective design, delivery and problem-solving skills
  • Proven track record of delivering projects in complaints management and/or establishing quality management systems (internally and/or externally)
  • Project team management experience leading a team greater than 5 FTEs, with a mix of internal and contractor team members, spread across multiple time zones
  • Working knowledge of US FDA 21 CFR Part 11 and EU Annex 11
  • Supplier qualification and management experience
  • Strong technology awareness (i.e. Oracle Agile PLM, ensur, and SharePoint)
  • Experienced in the application of Software Development Life Cycle (SDLC) methodologies and software change management.
  • Demonstrated experience as a Business or Systems Analyst, including process modelling

  • ASQ or AAMI certification
  • Experience of leading and implementing change initiatives and active stakeholder management
  • Experience of working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience
  • Experience of establishing and leading teams, and coaching and developing team members to maximize individual and team effectiveness
  • Experience as a System Administrator and/or configuration expert for
  • Additional languages (Continental European or East Asian preferred)

For further information on this Complaints Project Manager & Business Analyst role in Galway please contact Anne Marie Fox on 087 2197421 /

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