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.