Job Description
We are looking for a Process Quality Engineer to support manufacturing quality and process improvement initiatives within a regulated medical device manufacturing environment. The role will focus on implementing statistical quality tools, improving process capability, and ensuring compliance with regulatory standards such as FDA, GMP, and European regulations.
Key Responsibilities
* Develop and implement measurement systems, including destructive and non-destructive testing methods for manufacturing processes.
* Support design transfer and new product introduction, ensuring effective quality control plans are established.
* Develop and maintain process monitoring and control methods aligned with product risk and quality standards.
* Collect manufacturing data and conduct statistical analysis to support continuous improvement initiatives.
* Design and implement sampling plans and evaluate process capability based on product classification and defect risk.
* Conduct Measurement System Analysis (MSA) to evaluate the effectiveness of measurement tools and testing methods.
* Apply Lean and Six Sigma methodologies to identify improvement opportunities and drive operational efficiency.
* Ensure adherence to regulatory requirements including FDA, GMP, and European regulatory standards.
Mandatory Skills
* Knowledge of Manufacturing Processes
* Experience with Lean and Six Sigma methodologies
* Strong understanding of Measurement System Analysis (MSA), SPC, DOE, and Reliability engineering
* Proficiency with statistical software packages
* Strong working knowledge of MS Office tools
* Understanding of Regulatory Compliance (FDA, GMP, European regulations)