Quality Engineer II

The Engineer II - Quality Engineering plays a critical role in product development, risk management, regulatory compliance, and quality assurance.

This position ensures that new product development (NPD) and existing products meet regulatory and quality system requirements, working collaboratively with cross-functional teams to drive product excellence.

Key Responsibilities:

Product Development & Quality Compliance

• Ensure NPD processes comply with quality systems and regulatory standards.
• Conduct Design History File (DHF) gap assessments to identify and mitigate risks.
• Maintain and remediate risk management and design control files.
• Develop and execute test method validation and qualification plans.
• Support design changes and process transfer from development to production.

Risk Management & Compliance

• Conduct Benefit-Risk assessments for product complaints.
• Assist in resolving non-conformance issues.
• Ensure compliance with ISO 13485 and other relevant quality standards.
• Maintain quality documentation and regulatory filings.

Cross-Functional Collaboration

• Work closely with R&D, manufacturing, regulatory, clinical, and marketing teams.
• Provide technical support for design verification and validation activities.
• Collaborate on fixture development, process improvements, and quality control initiatives.

Required Qualifications:

• Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
• 2-4 years of experience in product development, quality assurance, or related fields.

Preferred Qualifications & Skills:

• Knowledge of Engineering & Quality principles (risk management, design controls).
• Understanding of ISO 13485 and medical device regulations.
• Experience in test method develQuality Engineeropment, validation, and fixture design.
• Print reading skills and experience with CAD software (SolidWorks, Creo).
• Familiarity with statistical techniques and software like Minitab or JMP.
• Strong problem-solving, analytical, and critical thinking abilities.
• Excellent documentation, communication, and organizational skills.
• Ability to manage competing priorities in a fast-paced environment.

17211 Redhill Ave Irvine California 92614 US

Education: Bachelors Degree