Medical Device QA Technician (Multiple Shifts)

• 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