QA Technician

Techlink Systems Inc

United States

United States

Jetzt Bewerben

Über

Job Title: QA Technician III Location: Sylmar, CA (ONSITE) Contract Duration: Contract until 10/06/2026 Working Hours: 8AM - 5PM Description : Looking for electrical or electronics background/exp. Performs more complex analytical tests (electrical and mechanical) required for trouble shooting to component level to determine failure mechanism on product returned from the field for analysis. Document nonconformances as appropriate. Monitor and/or perform calibration and maintenance of all test equipment and fixtures. Initiate related documentation changes. Perform Process Control & Monitoring of critical-to-quality parameters and specifications. Collect data, summarize, and document test results. Works with a computer (Microsoft applications such as word, excel, outlook), microscope and variety of diagnostic and test equipments such as oscilloscope, signal generators, multimeters, etc. Assist with the selection, installation and programming of precision measuring equipment. Create and maintain control plans for products and processes. Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Experience Details: Minimum 2 years 2-4 years experience. • Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning. Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements. Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design. Training in blueprint reading and experience with sampling techniques. Good communication and computer skills, including data analysis and report writing skills. Prior medical device experience preferred. ASQ CQT certification or equivalent preferred. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Preferred Qualifications: Associates degree, Technical training or additional technical certification Work experience in an environment that Complies with U.S. Food and Drug Administration (FDA) regulations Work experience within the Medical Device industry The job requires microscope experience. Around 10% to 20% of the work day will be spent using a microscope. Responsible for performing advanced inspections, reviewing device history records, supporting nonconformance investigations, and ensuring compliance with FDA 21 CFR 820, ISO 13485, and company quality standards. Experience with Class II or Class III devices is often preferred

United States

Sprachkenntnisse

English

Hinweis für Nutzer

Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klicken Sie auf „Jetzt Bewerben“, um Ihre Bewerbung direkt auf deren Website einzureichen.

Jetzt Bewerben