Quality Engineer 2 - Sustaining

Acumed LLC

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 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.

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.

Qualifications

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.