Senior MedTech Quality & Validation Engineer

NAMSA; Irvine (CA); On-site; USD 92,000 - 102,000; Full time

Job summary

NAMSA seeks an experienced engineer to manage equipment procurement and qualify MTE for biotech and pharma testing laboratories. You will design qualifications, analyze data, and ensure 21 CFR Part 11 compliance while maintaining documentation.

The role requires knowledge of regulatory standards and strong data and report-writing skills to support audits and ongoing validation activities.

Qualifications

• Bachelor degree in engineering or related scientific discipline required.
• Strong written and verbal communication skills.
• Knowledge of regulatory requirements, specifications, systems qualifications and protocols, and validation reports.
• Microsoft Word and Excel experience required.

Responsibilities

• Manage equipment procurement processes and assist in selecting/qualifying MTE for laboratories.
• Design and execute qualifications, requalifications and process validations of MTE to applicable standards.
• Analyze qualification data and generate final reports.
• Ensure data generated by equipment complies with 21 CFR Part 11.
• Maintain and update technical documents (protocols, SOPs, EOPs).

Skills

Regulatory knowledge

Documentation skills

Data analysis

Communication skills

Independent and team work

Education

Bachelor degree in engineering or related scientific discipline

Tools

Microsoft Word

Excel

Job description

NAMSA seeks an experienced engineer to manage equipment procurement and qualify MTE for biotech and pharma testing laboratories. You will design qualifications, analyze data, and ensure 21 CFR Part 11 compliance while maintaining documentation.

The role requires knowledge of regulatory standards and strong data and report-writing skills to support audits and ongoing validation activities.