Job Title: Quality Engineer - NPI & Tech Transfer
We are seeking a skilled Quality Engineer to support the introduction of new products and seamless transfer of manufacturing processes into production.
Main Responsibilities:
* Provide quality support for New Product Introduction (NPI) projects, ensuring compliance with regulatory requirements.
* Act as a key quality representative in technology transfer projects, collaborating with R&D, manufacturing sites, and suppliers.
* Drive process validation activities for new products and transferred processes.
* Identify and mitigate risks using Failure Mode and Effects Analysis (FMEA).
* Review and approve process development documentation.
* Lead non-conformance investigations and Corrective and Preventive Actions (CAPAs).
Requirements:
* Bachelor's degree in Engineering, Science, or a related discipline.
* Experience in NPI, technology transfer, or process validation within a regulated industry.
* Strong knowledge of Quality Systems and Risk Management.
* Hands-on experience with process validation and supplier quality management.
* Ability to manage multiple projects simultaneously.
Preferred Qualifications:
* Experience with ISO 13485, FDA regulations, GMP, and medical device/pharmaceutical industry requirements.
* Familiarity with statistical process control and Six Sigma methodologies.