Quality Engineer

Our client is seeking a Senior Quality Engineer to join their team. As a Senior Quality Engineer, you will be part of the Quality Engineering organization supporting one or more product lines at the Irvine facility. The ideal candidate will have strong documentation discipline, a proactive approach to quality risk reduction, and the ability to partner cross-functionally to drive continuous improvement.

Job Title:Senior Quality Engineer

Location:Hayward, CA

Pay Range:$55-60/hr. W2

What's the Job?

• Evaluate operational data, reports, statistics, and manufacturing documentation to generate proactive, timely actions that help reduce CIPM.
• Assure product compliance to specifications by implementing inspection criteria and procedures within operational processes, driving quality and manufacturing improvements to keep processes in a state of control.
• Develop and analyze statistical data and product specifications to support consistent product quality.
• Apply standard operating practices and structured problem-solving methodologies, including root cause investigations for negative trends, process failures, or critical characteristics not meeting requirements; document actions within the quality system as appropriate (NCR/CAPA).
• Organize, review, and perform computer system validation (CSV) or other software validation evaluations to support the Master Validation Plan, including support for data integrity initiatives for relevant systems, processes, and equipment.

What's Needed?

• Minimum of a BA or BS in Engineering with 3 to 5 years of related experience in Quality Engineering (a Masters degree may be used in lieu of 2 years of related experience).
• Demonstrated experience in process validation and risk management for medical devices.
• Engineering depth to understand product and process operating principles, control points and methods, design and process interactions, and end-user impact.
• Strong verbal and written communication skills, solid documentation practices (cGDPs), self-motivation, and strong interpersonal skills.
• Ability to update procedures and modify processes to simplify complexity and improve efficiencies; Lean or Six Sigma Green Belt or higher is preferred.

What's in it for me?

• Opportunity to support manufacturing quality from raw materials through finished device outcomes.
• Hands-on role maintaining Risk Management documentation and supporting quality risk reduction across product families and software defects.
• Engagement in validation planning and execution (e.g., DQ, IQ, OQ, PQ, TMV) to support regulatory and internal compliance expectations.
• Collaboration with product design, vigilance functions, Project Engineering, and Manufacturing Engineering to address quality issues and enable smooth transitions into day-to-day operations.
• Chance to coach and mentor the organization on CSV, SDLC, data integrity, and cyber security standards, regulations, guidance, and best practices.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.