Project lead and actively develop processes and procedures for the company QMS transition to ISO9001:2015, ISO13485:2016 and MDSAP. Perform quality systems compliance activities in support of the company’s activities. Assuring that quality systems procedures, processes, practices and controls are properly developed, implemented and maintained.
Work reviewed at project milestones and/or on completion by Senior Management. Work under minimal supervision. Lead and manage cross functional project teams to resolve complex quality systems compliance projects, which may have significant impact to the business e.g. QMS certification, product registrations etc.
Principal Duties and responsibilities:
- ISO Transition Project
- Participate in ISO9001:2015 and ISO13485:2016 projects and work with Project Manager, to manage and conduct relevant project activities across the organisation to ensure the achievement of ISO9001:2015 and ISO13485:2016 certification.
Such activities may include:
- Work closely with relevant management and process owners, provide process management expertise and translate ISO requirements to the relevant personnel
- Manage the relevant project work packages with relevant work package owners, lead relevant work package activities while facilitating a cross multi –functional team, to ensure on time delivery of project actions.
- Analyse various process issues and conformity concerns with relevant work package owners, to create solutions based on the context of the management system and associated processes. This may include organisational process re-structure, where applicable.
- Support process owners to define relevant process monitoring and measurement requirements, to ensure the achievement of customer requirements and to initiate future process improvement
- Assist the analysis of process monitoring and measurement outcome, to determine any improvement actions required with the relevant process owner.
Key Result Areas:
- Clear and communicated project plan for QMS transition to ISO9001:2015, ISO13485:2016 and MDSAP.
- Project actions and tasks completed on time.
- Regulatory compliance, Delivery of objectives & Demonstrate improvement.
- Ability to present information in a structured and balanced way
- Analytical Skill - Ability to visualize, articulate, conceptualize or solve both complex and uncomplicated problems
- Resilient and capable of managing potentially confrontational and/or difficult situations in a professional manner.
- Minimum 3 years’ experience in a Quality or related field
- Previous experience of ISO9001 (2008/2015) and ISO13485 (2003/2012/2016)
- Good working knowledge of Microsoft Office
- Lead Six Sigma (Yellow Belt or above) is highly desired
- Motivated to drive organisational and management system improvement, and capable of questioning and challenging company practices.
- Ability to work on his/her own initiative as well as part of a team
- Willing to travel and occasionally work unsocial hours
- 1st Degree in a scientific or engineering related discipline
- Certified Lead Auditor Qualification for ISO13485 and ISO9001 is highly desired
- Previous participation in Quality Improvement Project and any demonstrated Project Delivery would be highly desired