Job Description

Duties:

• 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

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