Skills

Statistical Analysis Monitoring Process Improvement

Job Specifications

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)

About the Company

"Empowering Technology Services” Founded in 2003, we are in our 22th year of structured growth. We are a talent-driven talent acquisition company providing individual consultants, project teams, and strategic outsourcing services to clients in various industries. E-Solutions is a certified minority-owned staffing firm spearheaded by industry experts. We offer award-winning solutions for the Global Talent Cloud. Our services include: • Workforce Solutions • Cloud Solutions • Salesforce Practices • Global Payrolling • MSP/V... Know more