Senior Validation Engineer
Reference: | SMC4566 |
Location: |
Limerick
|
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
- Managing Complexity/Technical Accountability Serves as technical expert for the Validation process and responsibilities to ensure compliance
- Continuous Learning/Managing Risk Resolves & manages technical operational problems in area of expertise
- Suggest and sometimes may implement innovation and continuous improvement within the
- Validation process Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Facilitates successful team behaviour within Quality Systems and across functional areas Manages relationships externally and internally.
- Builds cross functional and cross-departmental support, fostering overall effectiveness
- Fosters harmony within Quality Systems.
- Ensure accuracy and maintenance of the Validation Master List.
- Review and approve Validation Master Plans, Protocols, Summary
- Reports and other documentation associated with validations, as appropriate for each validation exercise.
- Ensure all validation activities and documents are authorised and appropriate compliance approval is gained.
- Ensure that all validation activities are carried out and reported in a timely manner.
- Ensure compliance through assisting in audits.
Experience & Education
-A degree level or similar qualification in mechanical or industrial engineering.
-Minimum 2 years experience in a quality role within a regulated industry.
-Proven knowledge and ability regarding product verification and process validations.
-Proven knowledge of FDA and MDD GMP requirements regarding medical devices.