Telephone: 086 8395533
Senior Quality Engineer
Our client, a medical device company in Limerick is currently looking to recruit a Senior Quality Engineer for their site.
Quality Systems development
- Begin to develop Quality system to support design activities
- Provides guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
- Support new product development activities to ensure work follows proper design control. Ensure controls meet company and FDA regulatory requirements by actively participating on product development.
- Guides the successful completion of major programs and may function in a project leadership role.
SW Development Guidance – support lab automation activities
- Help Facilitate Document review and approval with Diagnostic Systems BU.
- Assist with Test Case Reviews
General Guidance for Project/New Employee Onboarding
- Accessing C2C training/understanding DS training requirements
- Accessing SAP
- Accessing TFS
- Accessing Sharepoints
Test Instrument Consumables/Reagent Control
- Create Receiving and material handling SOPs
- Temperature Records Management (e.g. temp charts, OOS, etc.)
- OOS SOP/Investigation management
Lab Equipment Controls
- Calibration/PM – Managing, reviewing/approving/OOS investigations
- Blue Mountain RAM Access/Management (Data entry)
- IQ/OQ review/approval
- Liaison with Field Service Engineers to ensure proper documentation of servicing
Technology Development Understanding/Guidance
- Help project teams understand process and requirements
- Help facilitate technology integration (i.e. transfer to GPDS)
- Provides guidance to team and application of Design Controls 21CFR 820.30 for new product development.
- Creates and supports documentation.
For further information on this Senior Quality Engineer role in Limerick please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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