Quality Engineer II: Validation, PFMEA & NPI Lead

Manpower San Diego; San Diego (CA); On-site; USD 55,104,000 - 61,992,000; Full time

Job summary

A leading staffing agency is seeking a Quality Engineer II in San Diego, CA. This role involves validating analytical methods and providing quality leadership for new product development in the medical equipment sector. Candidates should have a Bachelor's degree in Science or Engineering and 0-2 years of relevant experience. The position is temporary and offers a pay rate of $40.00/hr to $45.00/hr.

Qualifications

• 0-2 years of experience in diagnostic, medical device, biotech or pharmaceutical company.
• Experience with change control process and documentation requirements.
• Experience with analytical method validation and cleaning validation.

Responsibilities

• Provide Quality leadership to new product development teams.
• Review and approve development studies and validation protocols.
• Perform risk assessment for Non-Conformance Events.

Skills

Proficient in validation methods and evaluation criteria

Experience with process validation

Experience with risk analysis and PFMEA

Working knowledge of CDRH, CBER regulations

Strong problem-solving skills

Good communication skills

Education

Bachelor's degree in Science or Engineering

Tools

Electronic document management systems

Job description

A leading staffing agency is seeking a Quality Engineer II in San Diego, CA. This role involves validating analytical methods and providing quality leadership for new product development in the medical equipment sector. Candidates should have a Bachelor's degree in Science or Engineering and 0-2 years of relevant experience. The position is temporary and offers a pay rate of $40.00/hr to $45.00/hr.