The Quality Control Inspector II (QCI) is responsible for initial Quality Control inspections of all NanoString incoming raw materials, components and sub-assemblies received at our facilities per inspection plan. QCI is also responsible for all finished instrumentation testing of all final assembled instruments per inspection plan. The scope of this position is includes performing all necessary quality control checks, including FAIRs (First Article Inspection Reports), using appropriate testing procedures and test instrumentation supported with appropriate documentation for all Nanostring products to manage quality risk and provide oversight over manufacturing processes. This position reports into the Sr. Quality Assurance manager which is part of Quality organization. The individual ensures consistent implementation, improvement, and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to; the FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic Directive (IVDD) and In-Vitro Diagnostic Regulation (IVDR).

Requirements:

• Technical diploma or equivalent AA in technical discipline. Relevant hands-on experience in a regulated industry.
• At least 3 years of experience as a QC inspector in a regulated environment i.e., medical device/ biotechnology/ aerospace industry.
• Analytical and creative problem-solving skills that include experience in leading and or participating on process improvement/lean projects.
• Excellent written and oral communication skills.
• Ability to work independently and collaboratively in cross-functional teams.
• Ability to multi-task with demonstrated problem solving skills in a fast-paced complex environment.
• Proficient in use of MS Office.

Essential Responsibilities:

• Perform incoming and final quality control inspections to support Manufacturing and Operations quality for all NanoString instruments following latest Incoming Specifications
• Update incoming inspection specifications and procedures as required, in collaboration with other affected departments.
• Record non conformances and support in conducting root cause investigations.
• Manage nonconforming (or potentially nonconforming) material through disposition.
• Perform lot validation testing while monitoring and adjusting testing frequencies.
• Support review and updating of SOPs relating to Quality Control Procedures.

• Collaborate with Manufacturing, Manufacturing Engineering, New Product Introduction, Procurement, Quality, and Supply Chain partners as well as vendors on the above activities.
• Basic application of statistical tools and methods.

Preferred Qualifications

• GD&T and CMM testing skills is a plus