Quality Engineer I

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 , and please be sure to include the title and the location of the position for which you are applying.