Job Description:
Acumed LLC
Position Title: Quality Engineer I
Company: Acumed LLC
Reg ID: JR0000026763
Location: Hillsboro, OR
Time Type: Full time
Description:
Acumed LLC
Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.
Job Scope
The Quality Engineer 1 - Sustaining is responsible for supporting all quality activities related to the production and inspection of sustaining products. The QE 1 – Sustaining drives Quality objective s 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
- 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
- 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
- Entry level with degree; not degreed requires 6 years of experience in quality assurance in a regulated environment
- Direct experience working with implantable devices preferred
- Understand quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
- Understand CAPA, failure investigation tools and techniques, and root cause analysis
- Effective communicator
- Proven track record of proficient teamwork and delivering results
- Working knowledge of Microsoft Office; proficient at Microsoft Excel
- ASQ Certified Quality Engineer desired
- Adaptable to fast paced, dynamic work environments with shifting demands
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:
With more than 100 autonomous manufacturing and service businesses, Marmon Holdings, Inc. may be the biggest company you’ve never heard of. Part of Berkshire Hathaway Inc., Marmon is a global industrial organization comprising 11 diverse groups with 20,000-plus employees and $10 billion in annual revenue.
As leaders in every industry we serve, Marmon companies have earned a great degree of independence. And our people thrive on an entrepreneurial spirit. At the same time, our group structure gives every Marmon company access to the expertise of other Marmon companies serving the same or related markets and customers – all with the support of the entire Marmon organization.
Working together, we become something more than the sum of our parts. We become the most reliable solution provider for a broad range of industries and customers worldwide.
In every case, Marmon’s success is due to our people. People with talent, drive and high ethical standards. People who are following their passions and building their careers across Marmon.
Want to learn and perfect your craft? Want to sharpen your skills while helping to solve challenges for our customers and our world? Looking for a chance to grow within – or perhaps outside – your field? Find a Marmon company that matches your passion. And see what you can do with the support of a team that values your contribution.
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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