Description
The QA Engineer job is based in Westmeath. This job is with one of the most recognised Medical Device Company's in Westmeath and offers huge opportunities for learning and growthAbout the Job:
Responsible for: Providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to the Quality Management program and for Supporting company goals, objectives, policies, procedures, quality systems, and FDA regulations.
Major Duties and Primary Responsibilities:
- Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instructions, and FMEA's for any product line changes/process improvements for new and existing products.
- Review and/or develop and execute facility, software, process and equipment validations and risk management documents
- Review change controls for process/design impact.
- Use knowledge of statistics to assist with validation developments and process improvements
- Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
- Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
- Complete NCMR and CAPA investigation, processing and disposition.
- Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
- Perform Internal Audits/Supplier Audits.
- Assist in the development, analysis and improvement of site Quality Metrics.
- Lead/Support project activity in your area of responsibility
- Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Will comply with all relevant training required and adhere to relevant associated documentation.
- Follow strict adherence to the requirements of CGMP.
- Liaise with suppliers to ensure drawings and specifications are clear, understood and fully compliant.
Benefits:
- Competitive Salary
- Great bonus -Full Healthcare - Pension
Requirements:
The successful candidate should have a Degree in Engineering or Science with preferably Five (5) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.
To Apply
Click apply in order to send your CV on for this position. If you do not have an up to date CV do not hesitate to contact me directly on the below number for a chat.
Point of contact for this role: Aaron O'Byrne /
Please see www.realstaffing.com for all exciting Quality Engineering jobs in the pharmaceutical/medical