Quality Engineer II
Irvine, CA
Schedule:
Standard Office Hours
Duration:
6-Month Contract
Pay:$41-46
Seeking a Quality Engineer II to join our team, supporting quality assurance initiatives and ensuring compliance with regulatory requirements in medical device development and manufacturing. This role will focus on quality engineering principles and methods to optimize internal and external manufacturing processes, as well as support product development activities.
Key Responsibilities:
- Provide support in Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for new product development (NPD).
- Lead or assist with test method development and validation for design verification and manufacturing inspections.
- Investigate manufacturing product quality issues, analyze results, determine root cause, and recommend corrective/preventive actions.
- Collaborate with cross-functional teams in engineering studies, feasibility testing, and design reviews.
- Support project risk assessments and escalation activities as needed.
- Partner with R&D and Manufacturing teams to facilitate product development and launch.
- Develop and execute validation protocols and process improvements to enhance manufacturing quality.
- Maintain and update risk management files in accordance with regulatory requirements.
- Develop and deliver training and documentation materials for production teams.
- Assign and oversee technician tasks, providing guidance and feedback.
- Perform additional responsibilities as assigned.
- Ability to travel up to 10% domestically and internationally.
Required Qualifications:
- Bachelor’s degree in Engineering with at least 2 years of experience in Quality Engineering, R&D, or Manufacturing; OR a Master’s degree in Engineering or a related Scientific field with internship or academic project experience.
- Experience in highly regulated industries (e.g., medical devices, pharmaceuticals, aerospace).
Preferred Qualifications:
- Prior experience in the medical device industry (e.g., cardiovascular, endovascular, or surgical products).
- Knowledge of Design Controls, Design Verification & Validation, Test Method Development, and Process Validation.
- Experience with root cause analysis, CAPA, and nonconformance investigations.
- Hands-on experience in risk management and regulatory compliance.
- Proficiency in Microsoft Office Suite, including Excel and Project.
- Basic understanding of statistical techniques and data analysis.
- Strong problem-solving, organizational, and analytical skills.
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