Senior MedTech Quality Engineer: Equipment & Validation

North American Science Associates, Inc.; Irvine (CA); On-site; USD 92,000 - 102,000; Full time

Benefits offered by this job

Equal opportunity employer

Fair Chance Employer

Job summary

NAMSA in Irvine, CA is seeking an experienced Equipment Qualification Specialist to lead procurement, installation, and qualification of laboratory M&TE in line with regulatory standards. You will design and execute validations, analyze data, and generate detailed reports for audits.

Responsibilities also include coordinating maintenance, ensuring 21 CFR Part 11 compliance for electronic data, and driving change-control activities with cross-functional teams.

Qualifications

• Bachelor degree in engineering or related discipline required.
• 5 to 7 years of related work experience preferred.
• Knowledge of regulatory requirements and validation protocols.

Responsibilities

• Manage procurement, installation, and qualification of M&TE for laboratories.
• Design/execute qualifications, requalifications and process validations per 21 CFR Part 820, ISO 17025, etc.
• Analyze qualification data and generate final reports.
• Ensure 21 CFR Part 11 compliance for equipment generating electronic data.
• Coordinate maintenance and upgrades; create CAPA and change-control plans.
• Write SOPs/EOPs and maintain equipment documentation in MMS.

Skills

Equipment procurement

M&TE qualifications

Process validation

Data analysis

Documentation/compliance

Troubleshooting

Change control

Training and mentoring

Regulatory awareness

Education

Bachelor degree in engineering or related scientific discipline

Tools

Equipment Management System

SOPs/EOPs writing

Job description

NAMSA in Irvine, CA is seeking an experienced Equipment Qualification Specialist to lead procurement, installation, and qualification of laboratory M&TE in line with regulatory standards. You will design and execute validations, analyze data, and generate detailed reports for audits.

Responsibilities also include coordinating maintenance, ensuring 21 CFR Part 11 compliance for electronic data, and driving change-control activities with cross-functional teams.