Ensure product is within quality standards and specifications to include maintaining quality and standards; visual inspections, measurements, and functional testing of product; recording data/test results to validate conformance; and assisting with quality related reports, reviews, and audits
Inspection output samples and complete forms/record findings of inspection process
Maintain inspection journals and summary logs
Train line personnel on quality issues and objectives
Complete Non-Conformance Reports for defective products and materials
Assist QA leaders in physical control of non-conforming products and materials
Complete staged production audits and document
Complete line clearance and setup inspections
Communicate quality problems
Complete operational paperwork validations as required (receiving, production shipping)
Complete staged shipment audits and support line reconciliation process
Complete quality related paperwork (i.e. Certificates of Compliance, Certificates of Analysis)
Monitor system inventory for accuracy
Participate in and support continuous improvement objectives
Record inspection results by completing reports, summarizing re-works and wastes, and inputting data into quality database
Train production team on quality control measures to improve product excellence
Propose improvements to production process
Monitoring equipment to ensure it is safe and discard those that do not meet requirements
Support new and on-going manufacturing efforts including final inspection, test of components and assemblies, and disposition of discrepant materials
Qualifications:
Bachelor's degree in quality, supply chain, transportation, or related preferred
2+ years of experience in Quality Control within the medical device industry
Solid Microsoft Office Suite
Experience in ISO 13485 or FDA regulated environment, GMP, ISO, or similarly regulated environment
Prior use of gauges, instruments, and other measuring devices
Attention to detail, focus on efficiency and accuracy, strong communication, collaboration, and coordination skills; team player with positive spirit and team goal focused
Commitment to growing job knowledge via educational opportunities and regular training
Other Info:
Business casual attire
Thriving and growing organization recently involved in acquisitions; 160 team members
Well rounded benefits package
Amazing company culture - collaborative, fun, down to earth, engaging, and approachable and motivating senior leadership