Quality Systems Engineer Hybrid
Collins McNicholas
- Co Westmeath
- Permanent
- Full-time
- Representing Quality function in Site Management meetings as required.
- Acting as a delegate for the Quality Lead.
- Lead investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering.
- Leading and implementing significant process improvements, projects and cost saving initiatives using data & quality tools to drive quality decisions. Initiating project plans, identifying resource allocations, performing and guiding technical activities such as risk documentation, procedural updates, test methods, process / software validation that have major importance to the business.
- Initiating, reviewing, approving, and providing guidance on change controls and change control process.
- Performing, analysing and interpreting statistical data using a detailed understanding of statistical tools and methods.
- Leading investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering. Leading the implementation of robust solutions.
- Ensuring QMS is implemented and adhered to by completing independent assessment of QMS documentation as required. Independently assess and provide guidance to Quality and Engineering disciplines.
- Provide periodic training for company personnel on the company's Quality System processes and procedures.
- Performing and leading Internal and Supplier Audits.
- Facilitating and participating in external regulatory body audits, e.g. ISO and FDA
- Implementing Key Performance Indicators within the Quality Assurance area to align with site and global quality objectives.
- Complete data analysis for Management Review.
- Co-ordinate collection of data for PMS.
- Actively lead QMS Process Improvement Projects
- Complying with all relevant training required and adhere to relevant associated documentation.
- Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Following strict adherence to the requirements of CGMP.
- Ensuring compliance to quality systems and all applicable regulations/standards, and internal procedures.
- Degree in Engineering or Science related field (minimum level 8)
- Lead Auditor or Internal Auditor certification an advantage.
- 5 years' experience working in a regulated environments, specifically medical device
- Strong knowledge of statistical tools and techniques
- Strong knowledge of FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools.
- Strong knowledge of problem solving techniques.
- Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
- Knowledge of the Quality System Regulation and associated regulations and standards.
- Attention to detail and accuracy is essential.
- Hybrid working flexibility on days
- Company Pension Contribution up to 10% company contribution
- Life Assurance - 4x salary
- Family Healthcare
- Long Term Disability benefit
- 25 days holiday increasing with service