Quality Engineer - Onsite | CSV & Risk Mgmt (6m)

Smartsearchonline; Hayward, Northern (CA, KY); Hybrid; USD 83,000 - 90,000; Full time

Job summary

Stefanini Group is seeking a Quality Engineer for the Hayward, CA site on a 6-month contract, onsite. The role spans from raw materials to finished devices, with emphasis on risk management, validation, and continuous improvement.

The candidate should hold a BA/BS in Engineering with 3–5 years of QA experience, and a Lean/Six Sigma Green Belt or higher is preferred. Strong communication and documentation skills are essential for success in this role.

Qualifications

• Minimum of a BA or BS in Engineering with 3–5 years related QA experience.
• Master's degree can substitute 2 years of experience; Engineering or MBA preferred.
• Lean or Six Sigma Green Belt or higher preferred.
• Experience with process validation and risk management for medical devices.
• Engineering depth to understand product/process interactions and end-user impact.
• Strong verbal and written communication skills and documentation practices (cGDP).
• Ability to update procedures and simplify processes for efficiency.

Responsibilities

• Evaluate operational data and documents to drive proactive actions for CIPM.
• Ensure product compliance by implementing inspection criteria in processes.
• Develop and analyze statistical data to guarantee quality.
• Apply standard operating practices and problem-solving methods.
• Perform root cause investigations and document NCR/CAPA actions.
• Review and perform computer system validation to support Master Validation Plan.
• Develop and maintain Risk Management documentation including software risk.
• Conduct validation activities (DQ/IQ/OQ/PQ/TMV) as assigned.
• Collaborate with Project and Manufacturing Eng to transition projects to operations.
• Assess software changes for validation, data integrity, and cybersecurity impact.
• Provide coaching on CSV, SDLC, data integrity, and cybersecurity standards.
• Other duties as assigned.

Skills

Verbal communication

Written communication

Education

BA/BS in Engineering

Master's degree considered for 2 years experience

Job description

Stefanini Group is seeking a Quality Engineer for the Hayward, CA site on a 6-month contract, onsite. The role spans from raw materials to finished devices, with emphasis on risk management, validation, and continuous improvement.

The candidate should hold a BA/BS in Engineering with 3–5 years of QA experience, and a Lean/Six Sigma Green Belt or higher is preferred. Strong communication and documentation skills are essential for success in this role.