Why QED? • Quiet Clean environment • Employees can wear headphones at their station • Growth Potential • Core hours - 1st Shift 7:00am to 3:30pm Why you? • Looking to put your experience to good use. • You like to solve problems • You 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 lives Then 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 RESPONSIBILITIES: • Perform inspections of purchased parts, subassemblies, in-process product and finished products according to defined criteria using standard physical, mechanical and/ or electrical measurements • Accurately and clearly document the results of inspections including quantitative measurements and observations • Draft or revise inspection documents based on feedback from management and observations of best practices • Work with Operations and Quality Management to drive continuous improvement of inspection methods and processes and meet departmental objectives • Perform 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 manner • Participate in quality audits of the quality management system • Other tasks as may be assigned by management QUALIFICATIONS: Education and Experience Required • High school diploma or GED; or equivalent combination of education and experience • Minimum of one year experience performing electrical or mechanical QC/QA inspections Preferred • Associate’s degree in a technical discipline • PCBA inspection experience and/or IPC 610 certification • Experience with ISO and FDA audits • Experience with QC/QA medical device inspection or test, especially MRI Skills and Abilities Required • Meticulous attention to detail – absolute must • Must be self-directed, self-motivated and able to work in a fast-paced team environment • A genuine belief in continuous improvement and disciplined processes • Self-starter with ability to multi-task and prioritize work day/projects independently • Excellent interpersonal and communication skills • Computer skills including working with word documents, spreadsheets, email and PLM/ERP business applications • Ability to follow good documentation practices (GDP)s Preferred • Understand and interpret mechanical drawings and electrical schematics • Working knowledge of printed circuit board (PCB) inspection standards (IPC-A-600) • Technical writing skills • Root 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 assessment Physical Requirements • Be able to lift 25 lbs. 7:00am to 3:30 pm OT available