Senior Quality Engineer

North American Science Associates • Irvine, CA

7d

About The Position

NAMSA is seeking a Senior Quality Engineer to support engineering and laboratory operations through the procurement, qualification, validation, maintenance, and documentation of measurement and test equipment (M&TE). The role applies regulatory and industry requirements to equipment and systems, investigates equipment issues, and helps ensure electronic data systems and equipment records are maintained appropriately.

The Senior Quality Engineer also supports laboratory staff through equipment training, continuous-monitoring and alarm investigations, equipment-needs planning, and audit support. The role contributes to process improvement, building expansion validations, engineering software administration, and maintenance of engineering drawings and equipment documentation.

Requirements

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

Responsibilities

• Manage equipment procurement and help identify or develop criteria for procuring and installing laboratory M&TE in accordance with testing standards.
• Design and execute M&TE qualifications, requalifications, and process validations under applicable regulations and standards.
• Analyze qualification, requalification, and validation data and prepare final reports.
• Work with IT to ensure equipment generating electronic data complies with 21 CFR Part 11.
• Investigate and troubleshoot equipment issues using advanced mathematical and engineering knowledge.
• Complete nonconformance, corrective action, and preventive action documentation.
• Prepare, review, and maintain technical M&TE documents, including protocols, reports, SOPs, and EOPs.
• Review raw data for qualifications, calibrations, and equipment service.
• Write and implement change-control plans and risk assessments.
• Coordinate and document scheduled and unscheduled equipment maintenance.
• Requalify, validate, and troubleshoot sterilizers and resistometers.
• Drive purchasing processes for materials and services needed by the relevant departments.
• Maintain and support equipment documentation in the Equipment Management System.
• Train laboratory and support staff on equipment use, and train associates on new and existing equipment and processes.
• Trend and analyze test equipment failures.
• Install, qualify, and maintain Siemens monitoring points.
• Assist laboratory personnel with continuous monitoring and alarm investigations.
• Administer and perform maintenance and upgrades for engineering software systems.
• Create and maintain associate user accounts for engineering systems.
• Write and execute building expansion validations.
• Update and maintain engineering drawings for buildings, equipment, and systems.
• Provide equipment records for client audits and act as a qualification and validation subject-matter expert where appropriate.
• Apply standard engineering techniques to improve processes and help laboratories identify equipment needs for proactive planning.
• Ensure electronic and paper equipment files are properly retired or archived.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior