Complaints Project Manager
Hero Recruitment
Mayo, Galway
Contact: Anne Marie Fox. Email: recruit@hero.ie. 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. Ensure the project meets the expectations of Quality and Regulatory compliance guidelines and satisfy FDA, ISO, internal and respective market & regulatory requirements. 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. 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. 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. 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. Qualifications/Requirements. Essential. 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. 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, SalesForce.com and SharePoint. Experienced in the application of Software Development Life Cycle (SDLC) methodologies and software change management. Desirable. ASQ or AAMI certification. Experience as a System Administrator and/or configuration expert for Salesforce.com. 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 / recruit@hero.ie. Check out all our open jobs on our HERO Recruitment website – www.hero.ie. Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. This job originally appeared on RecruitIreland.com.
2163 days ago