Senior Quality Engineer - Med Device Process Validation

Chipton-Ross, Inc.; Hayward (CA); On-site; USD 83,000 - 131,000; Full time

Job summary

Chipton-Ross, Inc. is seeking a Sr. Quality Engineer for a contract opportunity in Hayward, CA. The role focuses on process validation, risk management, and ensuring compliance across medical device manufacturing.

You will support manufacturing from raw materials to finished device, maintain the Risk Management process, and collaborate with design and vigilance teams to drive continuous quality improvement.

Qualifications

• Demonstrated experienced on process validation and risk management for medical device.
• Engineering depth and ability to understand product and process operating principles, control points and methods, design and process interactions and end user impact.
• Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
• Must be able to update procedures and modify processes to simplify complexity and improve efficiencies.

Responsibilities

• This position provides Quality Engineering support to one or more product lines at the Irvine facility.
• The Quality Engineer will support the manufacturing operation from raw materials to finished device, maintain the Risk Management process and related documentation, and closely interact with product design and vigilance functions to address quality issues and facilitate continuous improvement of product quality.
• Support the sustaining of production processes in a state of control and compliance through the planning, execution and implementation of process validation and controls to meet regulatory agency validation requirements, internal company standards and current industry practices.
• Authors and reviews validation processes and procedures, making recommendations for changes and/or improvements.
• Position may focus on equipment, process or control system validation or a combination there of.
• Evaluate all relevant operational data, reports, statistics and documentation related to manufacturing process and product performance to generate proactive actions.
• Assure product compliance to specifications through implementation of inspection criteria and procedures.
• Drives quality and manufacturing improvements to ensure processes are in state of control.
• Develop and analyze statistical data and product specifications to ensure product quality.
• Apply standard operating practices and problem-solving methodology.
• Perform root cause investigations and document NCR/CAPA actions.
• Organize, review and perform computer system validation or other software validation evaluations.
• Support data integrity initiatives to relevant systems, processes and equipment.
• Develop and maintain Risk Management Documentation including software risk.
• Perform validation activities (DQ, IQ, OQ, PQ, TMV).
• Partner with Project and Manufacturing Engineering for smooth transition of projects into operations.
• Evaluate and/or perform computer system validation for applicable software or GxP systems.
• Analyze software change controls for validation, data integrity, and cyber security impact.
• Provide coaching on CSV, SDLC, data integrity and cyber security standards and best practices.
• Other duties as assigned.

Skills

Process validation

Risk management

Documentation practices

Strong communication

Procedural updates

Education

BA/BS in Engineering

Master’s degree preferred

Tools

NCR/CAPA system

Computer System Validation (CSV)

Job description

Chipton-Ross, Inc. is seeking a Sr. Quality Engineer for a contract opportunity in Hayward, CA. The role focuses on process validation, risk management, and ensuring compliance across medical device manufacturing.

You will support manufacturing from raw materials to finished device, maintain the Risk Management process, and collaborate with design and vigilance teams to drive continuous quality improvement.