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.
- 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