Quality Inspector III - Medical Device

The Quality Inspector III works with Quality, Operations, Engineering, and Supply Chain to facilitate the inspection and testing of components, assemblies, and products to ensure they meet established specifications and requirements.Responsibilities:- Conduct inspections on incoming, in-process, and finished goods - Perform inspections of components, assemblies, and devices per applicable drawings and specifications.- Maintains accurate and up-to-date records of all materials. - Carefully review and check the accuracy of your own and others' work. - Provide input and support for product testing throughout the lifetime of the product (prototypes, DV&V, post-production, etc.).- Participate in the initiation and execution of nonconforming product actions. - Communicate with Engineers, Supply Chain, and other staff to resolve inspection questions.- Support the ISO, EN, and MDD certification processes and compliance with FDA regulations by ensuring compliance with all applicable policies, procedures, and guidance documents while performing assigned tasks and duties. - Contribute to a safe work environment by meeting company safety policies and all regulatory requirements.

Must-Have Skills:- 5+yrs of experience as a QC/Quality Inspector in the Medical Device field- Class II or Class III Medical Device experience - Incoming, In-Process, Final, and FAI Inspection experience - Proven background using hand measurements tools (i.e: caliper, snap gauge, pin gauge, micrometer, etc)- Experience with MicroVu (without it being fully automated) or Keyence - Experience with LHR/DHR Reviews- Strong Document Control experience including redlining drawings for engineering & updating procedures - Strong communication skills, both verbal & written- High School diploma required; BA/BS Degree in a technical field highly preferredBonus Skills:- Device/Component Tensile Testing - Ability to create a DCO (Document Change Order)- Catheter QC Inspection - Catheter Leak Testing- Experience with ERP Software- Senior/Lead-level experience with proven ability to take on additional delegated projects