Knowledge of ISO 9001:2015 / ISO13485:2016, 21 CFR 820's QMS. Proficient in Microsoft Excel, and Word, Ability to work collaboratively in a team environment.
Duties: Conduct thorough product inspections according to Standard Operating Procedures (SOPs) to verify compliance with design specificationsPerform incoming material inspections using vision inspection systems such as KeyenceGenerate Non-Conforming Material Reports (NCMRs) for products or materials that fail to meet specificationsCreate, maintain, and organize inspection records and retain samples according to quality protocolsProactively identify and recommend process improvements through critical thinking and problem-solvingVerify test equipment and tools are properly calibrated according to established calibration programsPerform additional quality-related activities as assigned by management Skills:
Experience with Metrology Inspection Equipment
Experience with SAP or similar ERP systems
Knowledge of ISO 9001:2015 / ISO13485:2016, 21 CFR 820's QMS
Proficiency with basic inspection tools (Calipers, Gauges, etc.)
Strong problem-solving, critical thinking, and organizational skills
Excellent written and verbal communication abilities
Proficient in Microsoft Excel, and Word,
Ability to work collaboratively in a team environment
Physical ability to lift and/or move up to 50lbs
Education:
High School diploma or equivalent
5+ years of Quality Control experience in the biomedical industry.