Quality Engineer 2/Metrologist (Sustaining)

Marmon Holdings•Hillsboro, OR

About The Position

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway— you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best. Job Scope The Quality Engineer 2/Metrologist is responsible for supporting all quality activities related to the production and inspection of sustaining products. The QE 2 drives Quality objectives in all sustaining activities, ensuring product and process conformance to global standards (including FDA AND ISO 13485). The purpose of this position is to serve as a Quality leader during manufacturing to ensure high product quality, reliability, and process capability and facilitate teams in identifying, documenting, assessing, correcting, and presenting quality issues using risk analysis and root cause analysis tools.

Requirements

Bachelor’s degree in an engineering or science discipline.
2+ years experience in quality assurance in a regulated environment.
No degree requires 8 years of experience in quality assurance in a regulated environment.
2+ years of experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.).
2+ years of experience with CAPA, failure investigation tools and techniques, and root cause analysis.
Working knowledge of GD&T (Geometric Dimensioning and Tolerancing)
Experience with CMM inspection systems; programming experience desired.
Experience with creation of inspection methods and TMVs.
Knowledge of quality and statistical analysis tools (e.g., SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
Highly effective communicator. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
Proven track record of strong teamwork and delivering results. Adaptable to fast-paced, dynamic work environment with shifting demands.
Working knowledge of Microsoft Office. Proficient at Microsoft Excel.

Nice To Haves

Direct experience working with implantable devices preferred.
ASQ Certified Quality Engineer desired.

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.