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NAMSA · 11 hours ago

Quality Engineer

Irvine, CA

Full-time

Onsite

Entry, Mid Level

$54K/yr - $90K/yr

2+ years exp

NAMSA is a pioneering company in the medical device materials industry, providing support throughout the product development lifecycle. The Quality Engineer will manage equipment procurement processes, design and execute qualifications and validations, and ensure compliance with industry regulations.

Medical Device

H1B Sponsor Likely

Responsibilities

Management of equipment procurement process and aids in identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories

Designs and executes qualifications, requalifications and process validations of M&TE as required by appropriate Biotech and Pharmaceutical industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025, etc.)

Analyze qualification, requalification and validation raw data and generate final reports

Assist with completion of equipment procurement documentation (e.g., equipment procurement form, requirement specification, etc.)

Work with IT to ensure equipment that generates electronic data is compliant with 21 CFR Part 11

Investigates and troubleshoots equipment issues and assists with nonconformance, corrective action and preventative action documentation where appropriate

Write and implements change control plans and risk assessments

Experienced with coordinating and documenting scheduled and unscheduled maintenance to maintain qualified laboratory equipment

Apply Engineering practices to ensure equipment is properly installed, maintained and labeled

Perform raw data review for qualifications, calibrations, and equipment service

Provide training on equipment use to laboratory and support staff where appropriate

Trend equipment calibration and performance failures

Maintains equipment specification and qualification data in the Equipment Management System

Install, qualify and maintain Siemens monitoring points for continual monitoring

Support maintenance and upgrades of Insight and InfoCenter software

Documentation of Equipment Service through Service Request Records

Obtain quotes and completes requisitions for outside service on behalf of owning departments

Purchase materials needed to complete equipment qualifications

Assist laboratory staff with assessment of equipment capabilities with respect to testing standards

Provide equipment records to appropriate staff as needed for client audits

Assist Equipment owners and Facilities staff with autoclave issue troubleshooting

Assist with writing, coordination and implementation of change control plans

Assist departments with ensuring lab equipment is compliant to appropriate standards/ranges/tolerances

Perform engineering and/or metrology assignments involving equipment or product design

Assist with training of Associates on new and existing equipment and processes

Apply standard engineering techniques to improve various processes

Prepare written technical documents such as protocols, final reports, SOPs, EOPs, and MNTs

Qualification

Equipment qualificationRegulatory knowledgeData analysisMicrosoft WordMicrosoft ExcelWritten communicationVerbal communicationOrganizational skillsTime managementTeamworkIndependent work

Required

Bachelor degree in engineering or related scientific discipline + 2-3 years of related work experience; or Associate degree with at least 5 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

Written and verbal communication skills

Strong organizational and time management skills

Able to excel both as part of a team and independently

Company

NAMSA

NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.

Founded in 1967

Northwood, Ohio, USA

1001-5000 employees

http://www.namsa.com/

H1B Sponsorship

NAMSA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)