careers / Quality Systems Engineer
Quality Systems Engineer
We are an Irish company that have devoted the past 30 years to delivering innovative custom automation, build to print and tooling solutions for the world’s most advanced manufacturers. Consecutively chosen as a Best Managed Company in Ireland by Deloitte for the past seven years, we are committed to always, always delivering the right solution. We specialise in designing and building bespoke, reliable, complete solutions which automate highly complex production processes. Through deep client collaboration we support our customers on the automation journey as they transition to smart methods of manufacturing that ultimately drive productivity and business efficiencies.
The Quality Systems Engineer will be responsible for driving Quality Lead Operational Excellence across all business activities at Modular Automation, a high technology Automation company working with customers in a FDA regulated manufacturing sector. The Quality Systems Engineer will utilize key Quality Management systems tools (Deviations, Complaints, Change Control, Internal/External Audits) to investigate and maximize business efficiency while embedding a culture of Continuous Improvement through Quality Assurance activities.
This is a Permanent position operating in the Quality Department and reporting to the Quality Manager.
The role of the Quality Systems Engineer is to lead and manage the site QMS including Document Control activities, Process mapping and standardization activities, reporting of quality trend data, and taking appropriate action. Supporting projects on all quality related issues; leading investigations of customer complaints/deviations and ensuring an effective and robust quality system which complies with all relevant regulatory requirements. The Quality Systems Engineer will also lead the internal audit program and support the Quality Manager with all aspects of preparation and hosting of external audits.
This role requires a very strong understanding of the principles of Quality Systems, Quality Assurance and Quality Control activities, QMS Process Optimization and strong analytical skills in gathering data from groups, defining work problems, and working with operational teams to design effective solutions to resolve problems.
- Minimum of 5+ years’ experience in QA/Compliance in a regulated environment.
- A third level Degree in a related Science or Quality Management discipline.
- Internal/Vendor Audit Accreditation would be preferable.
Key Skills & Attributes
- Strong knowledge of the ISO 9001 Directive
- Proficient in the Use of Problem Solving and CI tools
- Systems and Process thinking
- Process mapping capabilities
- SOP writing
- Enthusiasm for collaboration across Departments
- Good written communication skills
- Preference for a structured approach to working
- Time management
- Internal and External Customer focused
- Experienced in leading and supporting internal and external Audit programs.
- Knowledge of 21CFR Part 11 and ISO 13485 requirements, LEAN and 6Sigma would be an advantage.
- Responsible for day-to-day activities designed to maintain and enhance the local Quality Management System in line with ISO9001.
- To effectively manage and report all Quality Metrics including Deviations, CAPA’s, Change controls, SOP’s. Ensuring all actions are assigned and tracked to ensure compliance with critical quality KPI’s.
- Drive the understanding across the company of the cost of quality through Critical To Quality initiatives and Right First Time.
- Completion of Quality documentation e.g. Deviations, CAPA’s, SOP’s, Quality Control Documentation.
- Leads and supports cross functional investigations and CI projects.
- Assist in problem solving across the Business.
- Develop and implement systems to collect data to identify problems and to identify improvement opportunities.
- Supports the implementation of processes and systems to ensure that Quality/ CAPA related project work is completed as required.
- Handle assigned customer related query and lead the investigation of any complaint, liaising with the affected team to problem solve these queries if needed.
- Lead internal and support External/regulatory audits, including audit preparation, queries during the audit and follow up of actions to closure. Finalising CAPA’s and associated deadlines.
- Identify any opportunities for improvement of quality and customer service and support the team to implement continuous improvement initiatives/projects.
- Establish and manage key metrics in the areas of quality control, project delivery and customer satisfaction.
- Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures.
To apply, please send your CV and Cover Letter to email@example.com
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If you don’t see a match for your talents among our current open positions, please do still email your CV with a cover note to be considered for future opportunities.