This is an exciting opportunity to work with a leading medical device client.
Note: No sponsorship is provided for this long-term contract role. A valid visa is required.
Responsibilities:
* Own Event Investigation process and support CAPA system compliance ensuring timely closure of all Customer investigations.
* Support existing and new projects associated with manufacturing.
* Support all product and process audits as per Procedures.
* Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations.
* Identify and resolve complex exceptions to work assignments.
* Summarize, analyze, draw conclusions and make appropriate decisions from test results or other process-related findings.
* Have the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
* Ensure Corporate SOP alignment and compliance, ensuring all Site documents are kept aligned and completed on time, and interact and support the Regulatory Compliance officer in key tasks.
* Demonstrate flexibility to work across and support key Quality Department areas such as Customer Quality Engineering, Supplier Quality Engineering, and relevant QMS activities such as Internal Audit program, Performance excellence, Management review, Business Continuity Management, and Key Quality Projects working with Lean Six Sigma and Operations excellence lead.
What we need from you:
* A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
* A minimum of 3-5 years’ relevant experience, ideally within the Medical Device industry or another highly regulated environment.
* Previous experience with Operations/Manufacturing line support is advantageous.
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