Quality Engineer - 245781

Quality Engineer

Location : Williamston, MI

Pay : $34.75 / HR

Duration : 3-6 months

Responsibilities

• Oversee the development and execution of methods and procedures for process control, validation, improvement, testing, and inspection to ensure product functionality and compliance with specifications.
• Design and conduct experiments to identify and analyze sources of variation in products and processes. Utilize Statistical Process Control (SPC) techniques to assess current performance and evaluate the impact of changes.
• Plan and execute experimental product testing and data analysis to uphold quality standards and reduce defects and failure rates. Analyze quality data and defective product trends to drive corrective action initiatives. Apply statistical quality control and probability principles to support decision-making.
• Partner with supplier representatives to address quality issues, implement corrective actions (e.g., CAPA, SCAR), and support continuous improvement initiatives. Lead supplier qualification efforts.
• Provide quality engineering support throughout Product Development, including Design Controls, Risk Management, and preparation of CE Technical Files. Ensure proper documentation (e.g., Device Master Records) is created in alignment with regulatory requirements. Collaborate with Regulatory Affairs and suppliers to support 510(k) submissions, letters to file, and other regulatory needs. Coordinate product testing with internal and external labs as necessary.
• Ensure ongoing compliance with domestic and international regulations applicable to assigned product lines and processes. Conduct quality reviews of design documentation, vendor files, and company records to verify compliance.
• Lead investigations into product or process non-conformances and out-of-specification results, and develop and implement effective corrective and preventive actions (CAPA).

Qualifications