Senior Quality Engineer - Contract

Position: Senior Quality Engineer - Pilot Operations, Req# 19706-1
Location: Irvine, CA (100% onsite)

Duration: 9+ monthcontract with a high possibility of extension

Interview process

The anticipated process is two separate interviews: one with the hiring manager and one with the corresponding engineering partner. In-person interviews are preferred, with flexibility to consider a virtual interview when needed.

Schedule: Standard office hours. This assignment is not designated as temp-to-hire, and there is no approved permanent headcount attached to the requisition. Any future employment opportunity would depend on business needs and available openings.

Job Description:

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.

Education and 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.

Skills and Qualification:

• 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.

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 Edwards 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.