Senior Quality Engineer

Position Title: Senior Quality Engineer
Work Location: Irvine, CA 92614
Assignment Duration: 9 Months
Work Arrangement: Onsite
 
Position Summary:

• One contractor is needed for a nine-month assignment supporting a focused engineering program within the Quality team.
• The role applies installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and quality engineering principles to support compliant manufacturing processes and successful program execution.

 
Key Responsibilities:

• Support the assigned program’s IQ, OQ, and PQ activities, including validation planning, review, and execution support.
• Review and approve equipment validations and related asset-management actions. Participate in validation strategy development and review the program’s PVP/MVP validation planning documents.
• Ensure validation scope aligns with intended use, risk assessments, regulatory requirements, and the organization’s systems and procedures.
• Review process failure mode and effects analyses (PFMEAs) and process risk assessments to ensure critical process parameters (CPPs) and critical quality attributes are adequately addressed.
• Confirm prerequisite activities are complete, including equipment qualification, test method validation (TMV), software validation, fixture qualification, and drawing release, as relevant to the program.
• Verify the suitability of statistical rationale, sampling plans, and acceptance criteria.
• Develop, update, and maintain technical content in risk-management files; review and revise PFMEAs with the business unit’s PM team.
• Identify and support manufacturing-process improvements using engineering methods such as Six Sigma and Lean. Identify opportunities to improve equipment, tools, and fixtures and reduce process risk.
• Develop training materials and production documentation, including work instructions, to support transfer of project and manufacturing-process knowledge.
• Assign support tasks, instruct technicians conducting tests, provide training and feedback, and coordinate technician work as needed.
• Perform other related duties assigned by leadership.

 
Qualification & Experience:

• Bachelor’s degree in Engineering or a related field with four years of related industry experience required.
• Master’s degree or equivalent in Engineering or a related field with three years of related industry experience preferred; or Ph.D. or equivalent in Engineering or a related field with zero years of related industry experience preferred.
• Knowledge of IQ/OQ/PQ, quality engineering principles, manufacturing processes and equipment, and quality systems.
• Working knowledge of statistical techniques and their application to validation, sampling, and acceptance criteria.
• Strong technical documentation, problem-solving, organizational, analytical, and critical-thinking skills, with close attention to detail.
• Proficiency with Microsoft Office and strong communication, interpersonal, negotiation, and relationship-management skills.
• Ability to manage competing priorities, collaborate across departments and organizational levels, and coordinate with senior internal and external personnel.
• Ability to provide technical direction, train others, and influence improvements.
• Previous experience with laboratory or industrial equipment preferred.
• Certified Quality Engineer (CQE), Six Sigma, or Lean Black Belt certification preferred.
• Adherence to company requirements, safety procedures, and Environmental Health and Safety rules, including appropriate controls to prevent injury and protect the environment.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $55.00/hr – $57.00/hr.