Status: Filled
Job Title: Quality/Validation Engineer
Company: EXO PPE, LLC
Date: January 2021
Human Capital Consulting Partners has been retained by EXO PPE, a startup Medical Device Company located in East Norriton Township to conduct a search for a Quality/Validation Engineer.
This new position of Quality/Validation Engineer is responsible for developing and managing validation activities to ensure that all equipment, systems, products, and processes are in compliance with applicable regulatory requirements and industry standards.
Essential Functions/Duties:
- Actively manage the execution of all stages of the validation life-cycle.
- Develop new product quality management system to validate equipment and systems.
- Monitor equipment and software processes for adherence to established procedures and regulatory compliance.
- Develop, execute, and write commissioning and validation protocols and summary reports.
- Author, review, and approve technical documentation, protocols, and reports.
- Provide subject matter expertise for overall validation program during regulatory and partner inspections.
- Develop SOPs, maintenance procedures, calibration procedures, and other product support documentation.
Required Education and Experience
• Bachelor’s Degree in Engineering
• Minimum 5 years validation experience in a regulated environment
• Medical device experience required
• Experience working with NIOSH and FDA
• Experience with MasterControl Quality Management Software required
• Proficiency in Microsoft products including Outlook, SharePoint, Word, PowerPoint and Excel
• Excellent communication skills, both verbal and written, strong presentation skills
• Proven organizational skills including attention to detail