Senior Quality Engineer

Actalent is hiring for a Sr Quality Engineer in the Hayward area!

This role provides comprehensive Quality Engineering support for one or more product lines at a manufacturing facility in Hayward, CA. The Sr Quality Engineer supports operations from raw materials through finished medical devices, maintains and improves the Risk Management process and documentation, and collaborates closely with product design and vigilance teams to address quality issues and drive continuous improvement. The position sustains production processes in a state of control and compliance by planning, executing, and implementing process validation and controls that meet regulatory requirements, internal standards, and current industry practices.

The Sr Quality Engineer authors and reviews validation processes and procedures, recommends improvements, and may focus on equipment, process, or control system validation, or a combination of these areas.

• Evaluate operational data, reports, statistics, and documentation related to manufacturing processes and product performance in the field to identify trends and generate proactive, timely actions that reduce complaints and improve performance metrics.

• Assure product compliance to specifications by implementing effective inspection criteria and procedures within operations processes, and drive quality and manufacturing improvements to keep processes in a stable state of control.

• Develop and analyze statistical data and product specifications to ensure consistent product quality and compliance with requirements.

• Apply standard operating practices and structured problem solving methodologies to investigate and resolve quality and process issues.

• Perform root cause investigations for negative trends, process or product failures, and unmet critical characteristics, and prepare clear, comprehensive reports of findings and corrective actions.

• Document investigations and actions within the quality system using appropriate mechanisms such as Nonconformance Reports (NCR) and Corrective and Preventive Actions (CAPA).

• Organize, review, and perform computer system validation and other software validation evaluations to support the Master Validation Plan.

• Support data integrity initiatives for relevant systems, processes, and equipment, ensuring that data is accurate, complete, and reliable.

• Develop and maintain Risk Management documentation, including software risk assessments, for all product families and software defects.

• Plan and perform validation activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV), as assigned.

• Partner with Project Engineering and Manufacturing Engineering teams to ensure smooth transition of new projects and software changes into daytoday operations.

• Evaluate and perform computer system validation for applicable software and GxP computerized systems in alignment with internal standards and regulatory expectations.

• Analyze and assess software change controls for their impact on computer system validation, data integrity, hardware interactions, and cybersecurity.

• Provide coaching and mentoring to colleagues and stakeholders on computer system validation (CSV), Software Development Life Cycle (SDLC), data integrity, and cybersecurity standards, regulations, guidance, and best practices.

• Update procedures and modify processes to simplify complexity, improve efficiency, and enhance overall process robustness.

• Perform other related duties as assigned to support the quality organization and manufacturing operations.

• Demonstrated experience in process validation for medical devices, including planning, execution, and documentation of validation activities.

• Demonstrated experience in risk management for medical devices, including development and maintenance of Risk Management documentation.

• Engineering depth and strong ability to understand product and process operating principles, control points, methods, and the interactions between design and process, as well as their impact on end users.

• Proficiency with Good Documentation Practices (GDP) and current Good Documentation Practices (cGDP), with the ability to produce clear, accurate, and compliant documentation.

• Strong verbal and written communication skills, with the ability to convey complex technical information clearly to diverse audiences.

• Strong interpersonal skills and the ability to…