Job Overview:
Pay Range $47.1hr - $52.1hr
Requirement/Must Have:
- Bachelor's Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical) preferred.
- 3 to 5+ years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
- Demonstrates knowledge of investigations, root cause analysis, quality systems, the CAPA system and technical writing.
- Demonstrates excellent organizational and communication skills.
- Proficient with the MS Office Suite, and statistical software.
- Must be able to work independently with minimal supervision.
Responsibilities:
- Performs Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes.
- Ensures investigations and root cause analysis are accurate and complete.
- Maintain an accurate log of Non-Conformances and CAPAs activities.
- Tracks, follows-up and assists in the timely closure of NCs/CAPAs.
- Provides hands-on guidance and training to all personnel performing activities within the Quality system.
- Ensure documentation is complete before closure.
- Assist Quality Systems team as needed to investigate Nonconformances and ensure proper implementation of CAPAs.
- Prepare monthly and quarterly metrics to present at Quality Review meetings.
- Maintains a thorough understanding of the following regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485, Medical Device Directive (MDD), the Canadian Medical Device Regulations (CMDR), the Corporation's policies and procedures, and other applicable regulatory agency requirements.
- Interact and coordinate activities with other departments, external vendors and customers.
- Perform other Quality Systems related duties as required.
Benefits
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.