Job Details
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| Design Assurance Engineer | | |
| Location: | | Europe (Non UK) | | |
Description
Our client, a large multinational company based in Galway, now seeks a Design Assurance Engineer on an 18month contract.
Key Responsibilities
•Identifies and resolves complex exceptions to work assignments.
•Summarizes analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
•Continually seeks to drive improvements in product and process quality.
•Fully conversant with validation techniques, risk management, statistical techniques and associated regulatory requirements
•Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff. Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
•Interfaces with R&D, Clinical Marketing, Process Development and Manufacturing in a project core team environment providing technical and Quality systems input to the team.
•Is an active member of the project core team executing Quality deliverables as outlined in the Product Development Process (PDP), Recertification and Design Control SOPs
•Provides input to the Quality review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
•Be familiar with requirements and procedures that govern the Product Development Process and Design Control requirements.
•Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.
•Provide input on design control requirements to PDP/TDP teams and sustaining engineering activities in line with Corporate and BSC, Galway SOP’s
•Sustaining Engineering supports product lines post commercial launch - Typical activities include Life Cycle Risk Management; Supporting resolution of PIRs, Complaints, CAPAs, VIPs; Recertification; Regulatory Label Changes; Real Time Shelf-life studies; DHF Audit Support; Corporate SOP Changes
•Experience and technical and statistical capabilities in product development teams, Design verifications and validations
•Build Quality into all aspects of work by maintaining compliance to all quality requirements
Qualifications
•A graduate of Chemical/Engineering/Sciences or equivalent
•Minimum of 3 years experience in a pharmaceutical/Medical Device environment
For a confidential discussion and further information please contact Joe Dervan at 091 730022 or email | | |
Reference
IJ-JD/43080/IJP | | |
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