About Your New Employer
With operations in over 50 countries, over 180,000 employees and a world renowned managment philosphy, our client is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age.
About Your New Job
- You will be supporting quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- You will be reviewing/analyzing the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- You will be responsible for conducting benchmarking to develop more effective methods for improving quality
- Your role will include reviewing/analyzing whether current product and processes are in compliance to standards such as the QSRs, ISO 13485, etc.
- You will be responsible for conducting investigations, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Approve IQ, OQ, PQ, TMV or Software Validation
- You will be expected to document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs.
What Skills You Need
- A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 2-4 years related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
- Demonstrated project management and project leadership abilities are preferred.
What’s on Offer
For a confidential discussion on this or any other current job opportunity please contact Loren Pey on 021 484 7137 / lpey at sigmar.ie
Why Apply Through Sigmar?
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