Job Description
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
- 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 Salesforce.com 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
Qualifications/Requirements
Essential
- 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, SalesForce.com 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
Desirable
- 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 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
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