Quality Engineer - Med Device
- BBBH779138 Apr 01, 2021 Competitive
This is an excellent opportunity to join a successful and well-established business as they expand their product portfolio
I am delighted to bring this opportunity to market for any experienced Quality Engineers who are looking for a new opportunity. If you are looking for a role where you can join a successful and collaborative on site team, then this may be the role for you. This role is with a growing manufacturer in Cork and will be supporting the Operations, Engineering and Quality Management systems on site.
- Assist with the ongoing development of quality systems to assure alignment with current regulatory requirements.
- Support of external audits as required. FDA/BSI/Customer
- Ensures all activities in their assigned areas meet FDA and EU regulatory requirements.
- Development of IQ/OQ, Process Validation test protocols and reports to support product development and manufacturing process changes in compliance with control procedures.
- Support internal and supplier change requests.
- Raise NC's and CAPA's as required.
- Perform Root Cause analysis and appropriate corrective actions.
- Participate in performing and completing internal audits
- Supporting all activities required to ensure Quality Metrics are achieved.
- Drive continuous risk reduction through the completion of FMEA/DCP and associated risk analysis.
- As assigned, participate in new product transfers and be responsible for the development of quality plans, verification of engineering tests and measurement practices for new and existing products.
- Participate in the review of engineering specifications for NPI to ensure that quality assurance requirements are met and designs are successfully transferred into manufacturing.
- Review and investigate customer complaints,
- Participate in supplier control management.
- Be the voice of quality in a cross functional team.
Education & Experience required:
- A Quality/ Engineering/Science Degree or other relevant Third Level Qualification.
- 2 + year's quality/validation engineering experience in a Medical Device or other FDA regulated industry.
- Demonstrated knowledge of FDA and ISO requirements
- Previous participation in Regulatory or Customer Audits
- Ability to work in a high-intensity, fast-paced environment.
- Proven experience with CAPAs & Change controls.
- Validation experience to Medical Device Regulatory requirements a distinct advantage
- A Six Sigma qualification is highly desirable.
If you think your skill set matches the requirements or if you would like to find out more about this role, click the 'Apply Now' button or reach out to Kellie O' Donovan today on 021 2300 300 or email@example.com
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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Senior Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300