Senior Quality Engineer - MedTech Equipment Validation

namsa; Irvine (CA); On-site; USD 105,000 - 115,000; Full time

Job summary

NAMSA is a leading provider of medical device materials and services, supporting clients through the entire development lifecycle. The role focuses on managing procurement of measurement and test equipment (M&TE) for laboratories and ensuring compliance with testing standards.

The ideal candidate has a engineering degree, 5–7 years of experience, and strong knowledge of regulatory requirements and QA documentation, with hands-on experience in qualifications, validations, and documentation

Qualifications

• Bachelor degree in engineering or related scientific discipline required.
• 5 to 7 years of related work experience.
• Microsoft Word and Excel experience required.
• Knowledge of regulatory requirements, requirement specifications, systems qualifications and protocols, equipment operating procedures, standard operating procedures, and validation reports.
• Strong written and verbal communication skills.
• Strong organizational and time management skills.
• Able to excel both as part of a team and independently.

Responsibilities

• Manage equipment procurement process and qualify M&TE for laboratories per testing standards.
• Design and execute qualifications, requalifications and validations of M&TE.
• Analyze qualification data and generate final reports.
• Ensure equipment data handling complies with 21 CFR Part 11.
• Investigate and troubleshoots using advanced mathematical and engineering knowledge.
• Complete nonconformance, corrective action and preventative action documentation.
• Prepare, review and maintain written technical documents for M&TE, including protocols, reports, SOPs and EOPs.
• Perform raw data review for qualifications, calibrations, and equipment service.
• Write and implement change control plans and risk assessments.
• Coordinate and document scheduled/unscheduled maintenance of equipment.
• Provide training on equipment use to laboratory and support staff.

Skills

Written and verbal communication

Time management

Teamwork / collaboration

Education

Bachelor degree in engineering or related scientific discipline

Tools

Microsoft Word

Microsoft Excel

Job description

NAMSA is a leading provider of medical device materials and services, supporting clients through the entire development lifecycle. The role focuses on managing procurement of measurement and test equipment (M&TE) for laboratories and ensuring compliance with testing standards.

The ideal candidate has a engineering degree, 5–7 years of experience, and strong knowledge of regulatory requirements and QA documentation, with hands-on experience in qualifications, validations, and documentation