Integer Quality System Specialist II in Beaverton, Oregon
The primary purpose of this job is to lead and facilitate the administration and continuous improvement of the site’s quality system to ensure compliance with customer and regulatory requirements.
Key Accountabilities and Responsibilities
1. Adheres to Company Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2. Provides compliance guidance to Associates at a facility.
3. Plans, facilitates, tracks and coordinates internal and external audits.
4. Provides Quality Systems training orientation to new Associates. Updates orientation materials as needed.
5. Coordinates customers and notified body audits. Plans and coordinates appropriate documents and personnel required for audits (Front Room/Back Room).
6. Assists with quality assurance functions in support of needs directed by Quality Management.
7. Manage the timely response and closure of all audit observations and findings.
8. Reviews and maintains corrective actions from audit findings.
9. Provide metrics for audit status to management for Quality Management Reviews.
10. Prepare, coordinate and document the sites Quality Management Review.
11. Performs other functions as required.
- Minimum Education : Bachelor’s degree in a related field strongly preferred.
- Minimum Experience : 3-5 years within Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or regulated industry.
- Specialized Knowledge : Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.
- Special Skills : Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.
Other: Bachelor’s degree desired or equivalent related work experience required
Employee Type: Full-Time
- Location: Beaverton,OR
- Job Type: QA - Quality Control, Information Technology
- Experience: Not Specified
- Date Posted: 6/19/2017