Apply on Employer Site

Acumed · 1 day ago

Quality Engineer 2/Metrologist (Sustaining)

Hillsboro, OR

Full-time

Onsite

Entry, Mid Level

2+ years exp

Acumed LLC, part of the global industrial organization Marmon Holdings, is seeking a Quality Engineer 2/Metrologist to support quality activities related to sustaining products. The role involves ensuring product and process conformance to global standards, driving quality objectives, and facilitating teams in identifying and resolving quality issues.

Health CareManufacturingMedical Device

Responsibilities

Handles Non-Conforming Material Reports (NCRs and GNCRs) system and dispositions non-conforming products

Becomes familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinates issue resolution using a risk-based approach

Creates and maintains final inspection plans and works with applicable subject matter experts to develop and validate inspection methods, as needed

Trends and reports on quality data in order to improve product and process; develop recommendations based on data analysis. Quality Review and Management Review support

Subject matter expert for GD&T and CMM

Provides management with status updates on assigned responsibilities/goals and escalates issues as needed

Leads and supports quality investigations and root cause determinations

Supports internal and external audits

Owns CAPAs

Issues/manages SCARs

Runs/supports ECOs

Supports inspection method development and TMVs (Test Method Validation)

Writes/approves HHEs

Supports field actions

Writes and updates-controlled documents in Windchill

Serves on cross functional teams to resolve quality aspects of company issues

Interfaces with suppliers on quality issues

Qualification

Quality assurance experienceISO 13485 knowledgeRoot cause analysisGD&T knowledgeCMM inspection experienceCAPA experienceStatistical analysis toolsMicrosoft OfficeASQ Certified Quality EngineerEffective communicationTeamwork