Quality Inspector

Job DescriptionJob DescriptionWhy QED?Quiet Clean environmentEmployees can wear headphones at their stationGrowth PotentialCore hours - 1st Shift 7:00am to 3:30pmWhy you?Looking to put your experience to good use.You like to solve problemsYou like with working with your hands, and your good with them.You like having detailed instructions.You think electronics are interesting.You want to make a difference in people livesThen please join us as a Product Quality Inspector!JOB SUMMARY We are seeking a detail-oriented and quality-driven Product Quality (PQ) Inspector to join our team. In this role, you will be responsible for ensuring the highest standards of quality and compliance across incoming materials, in-process production, and finished medical devices. You will conduct inspections, functional testing, and evaluations using a variety of measurement techniques, while accurately documenting results in accordance with established quality systems and Good Documentation Practices (GDP). ESSENTIAL DUTIES AND RESPONSIBILITIESPerform inspections of purchased parts, subassemblies, in-process product and finished products according to defined criteria using standard physical, mechanical and/ or electrical measurementsAccurately and clearly document the results of inspections including quantitative measurements and observationsDraft or revise inspection documents based on feedback from management and observations of best practicesWork with Operations and Quality Management to drive continuous improvement of inspection methods and processes and meet departmental objectivesPerform review of device history records (DHRs) and other documentation for compliance to established procedures and good documentation practices (GDP)Write non-conformance reports. Ensure non-conformances are closed in a timely mannerParticipate in quality audits of the quality management systemOther tasks as may be assigned by managementQUALIFICATIONS:Education and ExperienceRequiredHigh school diploma or GED; or equivalent combination of education and experienceMinimum of one year experience performing electrical or mechanical QC/QA inspectionsPreferredAssociate’s degree in a technical disciplinePCBA inspection experience and/or IPC 610 certificationExperience with ISO and FDA auditsExperience with QC/QA medical device inspection or test, especially MRISkills and AbilitiesRequiredMeticulous attention to detail – absolute mustMust be self-directed, self-motivated and able to work in a fast-paced team environmentA genuine belief in continuous improvement and disciplined processesSelf-starter with ability to multi-task and prioritize work day/projects independentlyExcellent interpersonal and communication skillsComputer skills including working with word documents, spreadsheets, email and PLM/ERP business applicationsAbility to follow good documentation practices (GDP)sPreferredUnderstand and interpret mechanical drawings and electrical schematicsWorking knowledge of printed circuit board (PCB) inspection standards (IPC-A-600)Technical writing skillsRoot cause investigation skills and an understanding of various investigative methods (5 Whys, Fault Tree, etc.)Risk evaluation skills (PFMEA, Fault Tree) and rework adverse effect assessmentPhysical RequirementsBe able to lift 25 lbs.7:00am to 3:30 pm OT available