We are looking for Quality Engineer for our client in Columbia MD.
Job Title: Quality Engineer
Job Location: Columbia MD
Job Type: Contract
Job Overview:
Pay Range: $47.10hr - $52.1hr
Requirement/Must Have:
- Bachelor of Science or higher; Master s degree is preferred.
- Technical specialization in change management and data integrity, systems development/validation, or data/trending.
- Demonstrates an understanding of statistically-based sampling plans, application of analytical tools, and has a history of data driven decision-making.
- Demonstrates excellent organizational, communication, and project management skills.
- Ability to prioritize projects to meet organizational goals and objectives.
- Demonstrates knowledge of the principles of data integrity.
- Proficiency in the use of modern technology, especially electronic quality management systems, enterprise resource management systems, and the Microsoft suite of applications.
- Ability to work independently with minimal supervision.
- Knowledge of international standards and maintaining the currently recognized state-of-the-art.
- GMP experience required in controlled / regulated environments.
- Data Integrity experience is a huge plus.
Responsibilities:
- Support business operations by maintaining critical management systems and assuring the efficacy of established process control programs, including calibration and maintenance, change management, validation, and environmental monitoring.
- Participate on and lead cross-functional, problem-solving investigation and development teams.
- Provide guidance on the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation documents, manufacturing procedures, product & material specifications, and SOPs.
- Facilitate the development, implementation and monitoring of quality programs and policies to ensure compliance with applicable regional regulations, international standards, and corporate policies.
- Maintain a thorough understanding of international standards and regional regulations including FDA QMSR (21 CFR Part 820), principles of Data Integrity and 21 CFR Part 11, ISO 13485, Regulation 2017/745 (EUMDR), and CMDR.
- Support the launching of new or improved products/processes and facilitate the transfer of technology from development to commercialization.
- Facilitate management of changes in device design and manufacturing procedures for commercialized devices.
- Author, edit, and provide guidance on the development of validation protocols and reports, product & material specifications, design & development documentation, and quality investigations.
- Investigate Quality Events using a systematic approach to determine root causes.
- Develop objective evidence to supplement data driven decision making.
- Support development of statistically based sampling plans for product testing, inspections, and validations.
- Provide Statistical Analysis of data to support Quality Systems documentation such as validations, NCs, and Complaints.
- Develop, review, and approve validation documentation for new and existing products, processes, and equipment.
- Prepare monthly and quarterly trending data and analysis reports, including Statistical Process Control documentation.
- Participate in FDA inspections, ISO Certification and surveillance audits, and customer audits.
- Facilitate and maintain the change management system, completing quality impact assessments and assuring change controls are complete and on-time.
- Perform Quality Investigations in response to quality events, implementing corrective and preventive actions.
Nice to Have:
- American Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS) certificates.
- Coding/scripting proficiency and/or experience validating complex data management networks.
Skills:
- GMP.
- Data Integrity.
- ISO 13485.
- FDA QMSR (21 CFR Part 820).
- 21 CFR Part 11.
- EUMDR.
- CMDR.
- Statistical Process Control.
- Change Management.
- Validation.
- Quality Management Systems (QMS).
- Enterprise Resource Management Systems.
- Microsoft Office Suite.
Qualification And Education:
- Candidates who are not certified must demonstrate technical competency by obtaining a relevant certification from an accredited organization within the first year of employment.
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.
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