QC Inspector - 1st Shift

About the role

The QC Inspector performs sampling, inspection, testing, and sampling of incoming materials; conducts required in-process and final inspection of reprocessed devices and their packaging; performs pre- and post-sterilization inspection of batches and review of Batch Production Records (BHRs). Strictly follows and enforces established procedures and policies needed to meet the demands of Quality in a regulated medical device company.

Responsibilities

• Perform inspections of purchased components, reprocessed devices and their packaging, sterilization records, and Batch History Records (BHRs) to controlled procedures and pre-determined acceptance criteria.
• Accurately document the results of the inspections and testing.
• Participate in the creation and/or revision of procedures for the inspection function.
• Ensure appropriate labeling, storage, and handling of product and materials throughout the manufacturing facility to prevent mix-ups.
• Ensure Quarantine areas are orderly maintained and scrapping requests made by the Materials Review Board (MRB) are fulfilled.
• Update material status in ERP system following the completion of Quality activities.
• Ensure line clearance and material reconciliation activities are conducted as dictated by company procedures.
• Assist with nonconforming product investigations, CAPAs, and customer complaints.
• All other reasonable duties, as assigned.

Requirements

• High School Diploma or equivalent; 1-2 years of Quality Inspection experience is preferred.
• Good English written and verbal communication skills; good arithmetic skills are required.
• Mechanical aptitude and working knowledge of measuring instruments is desired.
• Experience with 21CFR820, Quality Systems Regulation, and ISO 13495 is a plus.
• High level of attention to detail in completion of tasks and cross-referencing of information in several locations.
• Ability to multi-task and prioritize in a fast-paced environment, and flexibility when juggling numerous projects simultaneously.
• General proficiency in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
• Experience with J.D. Edwards ERP software is a plus.
• Ability to grasp instructions and information rapidly and apply them with little supervision; self-motivated, self-starter.
• Strong verbal, written, organizational, time management, and interpersonal skills.