Description
Acumed LLC
Position Title: Quality Engineer 2 - Sustaining
Company: Acumed LLC
Req ID: JR0000038959
Location: Hillsboro, OR
Time Type: Full time
Description:
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
- 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.
- Direct experience working with implantable devices preferred.
- 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.
- ASQ Certified Quality Engineer desired.
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.
About Us:
Welcome to the biggest small business you'll ever find. Part of Berkshire Hathaway, Marmon is a global industrial organization made of 11 industry groups with 30K employees and $12 billion in annual revenue.
As leaders in their respective industries, our 120+ companies thrive on an independent mindset and entrepreneurial spirit. At the same time, they benefit from being part of our industry groups—where they're able to tap into the expertise and insights of other Marmon companies.
While we're all unique, we all share a common commitment to doing things that matter, leading at every level, and winning a better way.
Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.
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