Metrologist

Viant Medical•Upland, CA

37d

About The Position

We're a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, We're in It for Life. The Metrologist is primarily responsible for designing and building test fixtures, establishing measurement methods and performing measurement system analysis. The position will support engineering and production projects and processes relating to Metrology. In addition, the role will support all aspects of quality assurance including first article inspection generation, capability studies, DOE, developing procedures, root cause analysis, corrective and preventative actions.

Requirements

Bachelor of Science degree in Engineering or related field
5+ years of experience in injection molding or similar manufacturing industry.
Proven experience working as a Metrologist, including calibration, inspection, and maintenance of precision measuring instruments.
Knowledge and familiarity with OGP (Optical Gauging Product), CMM (Coordinate Measuring Machine), and other precision measuring devices used to ensure product quality and compliance. (Must)
Proficient in reading and interpreting engineering blueprints.
Strong understanding of GD&T requirements and their application in manufacturing and inspection processes.
Ability to perform various computer-related tasks using programs including, but not limited to: Microsoft Office Suite - SolidWorks - Minitab - ETQ - IQMS - Infinity QS - MEASUREMIND - Zone3 CALYPSO
Strong organizational abilities with a proven track record of managing multiple tasks simultaneously.
Solid understanding of QMS regulations, including complaint handling, NCR (Non-Conformance Reports), containment, and root cause analysis.
Working knowledge of interpretation and application of relevant regulations and standards, such as: FDA 21 CFR Part 820 and ISO 13485:2016

Responsibilities

Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
Design and develop new gaging and fixturing for part measurement.
Program inspection routines to support injection molded and assembled components.
Assess and implement improvements of production and NPI inspections routines and fixtures to increase throughput.
Participate in review of manufacturing and testing of new products to assure quality requirements are fulfilled.
Provide training as needed on new procedures being enforced. Support Inspection Function, training employees engaged in inspection and testing activities to ensure compliance to procedures and policies.
Own CAPA, Complaints, Calibration OOT and Non-Conformance events from initiation to closure.
Responsible for generating Inspection sheets and control plans to meet customer drawing and specification requirements.
Assures compliance to in-house and external specifications and standards, such as GMPs and ISO regulations.
Interface with customers, vendors, and 3rd party assessors, as needed.
Support Internal, Customer and Regulatory body audits as needed.
Other projects and tasks as assigned.