Overview
Software Quality Engineer Jobs in Tewksbury, MA at Compunnel Inc.
Title: Software Quality Engineer
Company: Compunnel Inc.
Location: Tewksbury, MA
Job Summary:
The Software Quality Engineer will be responsible for standardizing and streamlining validation processes across the life science division(s), ensuring that compliant software is delivered to internal and external customers. This position will involve working closely with cross-functional teams to ensure proper documentation, verification, and validation of software requirements.
Key Responsibilities:
• Standardize and streamline software validation processes to ensure timely availability of conforming, compliant software.
• Coordinate with functional groups to ensure proper documentation and verification/validation of software requirements.
• Drive continuous improvement initiatives within the organization.
• Serve as the Quality representative on projects of varying scale and complexity.
• Champion software IQ/OQ/PQ validation systems within the organization, acting as a Subject Matter Expert (SME), Trainer, and Coach.
• Apply best quality engineering practices to support project teams in software user requirement creation, verification, and validation.
• Perform internal audits to ensure compliance with quality systems.
• Create technical documentation that meets business needs while adhering to applicable international standards and regulatory requirements (e.g., ISO, FDA, EU, etc.).
Required Qualifications:
• BS degree in a relevant field (Bachelors Minimum Required).
• 5+ years of experience in pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering/assurance.
Preferred Qualifications:
• Product application knowledge and experience.
Minimum Qualifications:
• Experience in 21 CFR Part 11-compliant software validations, including systems such as inspection systems, vision systems, manufacturing execution systems, and material handling systems.
• Knowledge of applicable industry standards, regulations, and requirements (e.g., GAMP, GMPs, ISO 9001, ISO 13485, QSR 21 CFR Part 820).
• Familiarity with manufacturing and business software for data collection, project management, statistics, word processing, communication, and other operational management systems.
• Advanced working knowledge of Microsoft Office applications.
• Strong communication skills with the ability to work with all levels of the organization.
• Ability to influence others with objective insight and best practices.
• Ability to work independently and prioritize tasks effectively in a fast-paced environment.
• Experience influencing individuals without authority and motivating project team members.
• Ability to make objective decisions regarding software suitability and conformance.
• Action-oriented with strong decision-making and problem-solving abilities.
• Excellent organizational skills and ability to manage multiple assignments efficiently.
• Flexibility to assume ownership of projects and coordinate efforts with cross-functional teams.
• Knowledge of manufacturing processes and relevant software quality assurance practices.
• Thorough understanding of validation in the context of integrated software systems.
• Ability to adapt to change and take on additional responsibilities as needed.
