Quality Engineer I

About the role

As a Quality Engineer I you will utilize quality engineering principles, tools, and practices to develop, transfer and maintain products and processes throughout the product's lifecycle, ensuring that products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements. In addition to this, you will use risk management and problem solving skills to prevent unanticipated failure modes and improve capability of products and processes through recommendation of preventive and corrective actions. Responsible for executing all items regarding quality issues, complaints, validations, and other projects in support of life science and/or clinical diagnostic product manufacturing.

Location

Location: This position must be based in Hercules, CA and requires the employee to be located within commuting distance of the office.

Responsibilities

• Providing engineering support to manufacturing and conducting the evaluation and disposition of nonconforming product and process-related issues using a risk-based approach to resolve problems impacting production fulfillment.
• Spending time on the manufacturing floor to identify process improvements, participating in investigations, root cause analyses, corrective action planning and implementation activities, and interfacing with cross-functional departments to improve product quality using recognized Six Sigma and Lean methodologies.
• Ensuring compliance with internal and external safety, quality, and regulatory requirements (e.g., FDA and ISO standards) by reviewing and approving product and quality system changes in partnership with Engineering and Manufacturing.
• Participating in Quality Review Boards, performing data analysis using appropriate statistical tools and techniques to identify trends, developing technical investigation plans, and recommending updates to quality standards and procedures as needed.
• Executing New Product Introduction (NPI) and Design Transfer activities by characterizing manufacturing processes for parts and components in development to ensure a successful transition from R&D to manufacturing, including participation in and leadership of equipment and process validation activities (FMEA, IQ, O