Sr. Quality Engineering Technician
On-siteAlajuela, Alajuela Province, Costa Rica
Job Summary
Perform incoming, in-process, and final inspection activities for NPI and transferred products while conducting in-process audits during ramp-up to verify compliance with procedures and control plans. Support Quality Engineers with data collection, sample preparation, documentation review, and execution of IQ, OQ, PQ, process characterization, and TMV activities. Document nonconformances, deviations, and related quality records, and support follow-up actions as assigned. Assist with troubleshooting ramp-up and production issues by collecting data, identifying gaps, and escalating concerns to engineers. Provide hands-on support to production, NPI, and transfer teams during ramp-up to help stabilize processes and improve first-pass quality. Resonetics is a global leader in advanced engineering and micro-manufacturing driving innovation in the medical device industry.
Required Qualifications
- Quality technician degree or associate degree
- Minimum 2 years of experience in quality control, inspection, manufacturing support, or a related role in a regulated environment
- Direct hands-on experience supporting NPI, product transfers, process transfers, process validation, or manufacturing scale-up
- Experience with visual and dimensional inspection, microscope use, and measurement equipment
- Ability to read work instructions, procedures, and basic technical documentation
- Strong attention to detail, organization, communication, and follow-up
- Ability to work under minimal supervision and support multiple priorities
- Basic working knowledge of Microsoft Office applications
- Professional working English, written and spoken, sufficient to follow instructions and communicate clearly with the team
- Valid U.S. visa in good standing and ability to travel to the United States as business needs require
Desired Qualifications
- Medical device manufacturing background preferred
- Experience supporting NPI, transfers, ramp-up, in-process audits, or quality system activities
- Familiarity with ISO 13485, FDA requirements, CAPA, NCR, and document control is desirable
- Certified Quality Technician, Six Sigma Green Belt, Six Sigma Yellow Belt, or equivalent quality/statistical certification
- Experience with catheter-based devices, minimally invasive devices, complex assemblies, Class II / Class III medical devices, and/or manufacturing components and processes related to Nitinol
- Experience with customer-to-site, site-to-site, or line transfer projects
- Experience in contract manufacturing or customer-facing medical device operations
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