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.