QC Inspector - 1st Shift

The QC Inspector performs sampling, inspection, testing, and sampling of incoming materials; conducts required in-process and final inspection of reprocessed devices 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.

Essential Duties and 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.
• Ensures appropriate labeling, storage and handling of product and materials throughout the manufacturing facility to prevent mix-ups.
• Ensures Quarantine areas are orderly maintained and scrapping requests made by the Materials Review Board (MRB) are fulfilled.
• Responsible for updating material status in ERP system following the completion of Quality activities.
• Ensures 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.

Education, Qualifications and Skills:

• High School Diploma or equivalent; 1-2 years of Quality Inspection experience is preferred.
• Must have good English written and verbal communication skills; Good arithmetic skills are required
• Mechanical aptitude and working knowledge of measure instruments is desired
• Experience with 21CFR820, Quality Systems Regulation and ISO 13495 a plus.
• Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several locations.
• Must demonstrate the ability to multi-task and prioritize in a fast-paced environment, and possess 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 use a plus.
• Must grasp instructions and information rapidly and apply them with little supervision self-motivated, self-starter.
• Strong verbal, written, organizational, time management and interpersonal skills.