Engineer I – Quality Systems

Engineer I – Quality Systems

Requirements

• Bachelor of Science Degree in Biomedical Engineering, Mechanical Engineering, Engineering Technology, or similar discipline required.
• Minimum one year of experience in the pharmaceutical or medical device industry is preferred.
• Experience with document and record control in regulated industries is preferred.
• Strong judgment and creative problem-solving skills.
• Excellent oral and written communication abilities.
• Strong interpersonal skills and the ability to work well in team settings.
• Highly organized, capable of managing multiple competing priorities efficiently.

Responsibilities

• Write and revise procedures and controlled documents by collaborating with relevant stakeholders.
• Support internal and external audits and inspections by preparing reports and documentation.
• Ensure compliance with regulatory requirements and company procedures.
• Execute the components of the quality management system and support relevant stakeholders through their execution.
• Participate in risk assessments, investigations, and process improvements.
• Maintain alignment with stakeholders to continuously improve the system.
• Assist in the management and completion of quality records such as deviations, CAPAs, and change controls.
• Participate in trending and reporting of Quality System metrics.
• Document and Training Management.
• Generate, issue, and reconcile executable documents in alignment with site operations, where applicable.
• Act as a liaison between document authors and approvers to support efficient document workflow.
• Maintain and improve the document control room, including physical and digital file management, where applicable.
• Provide training support and act as system administrator within the electronic Quality Management System.
• Assign onboarding and role-based training for staff, ensuring proper documentation.
• Ensure timely and accurate filing, shipment, and archiving of documentation.
• Review validation deliverables (draft and executed) for compliance with internal procedures and regulatory standards.
• Collaborate with system/process owners on validation and data integrity risk assessments.
• Draft and review changes, deviations, periodic reviews, and quality records related to computerized systems.
• Contribute to validation planning for new systems and processes.
• Lead and/or assist with training related to CSV and Data Integrity practices.
• Work closely with IT, QA, and cross-functional departments for alignment on system validation.
• Support the organization with up to 25% travel for validation-related activities or audits.

Preferred Qualifications

• Minimum one year of experience in the pharmaceutical or medical device industry is preferred.
• Experience with document and record control in regulated industries is preferred.