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Quality Engineer
Career Insights for Validation Specialist
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Scorecard
Based on Maryland data
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What they do
A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
$91,975 / year median in Maryland
+10% projected growth
Job Description
Quality Engineer
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. Visit the Employer site for more details
Benefits
- Dental Insurance