Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
Required Education:
4 Year Degree
EXO PPE, LLC a startup Medical Device Company located in East Norriton Township,PA is in need of a Quality/Validation Engineer. Note: May eventually become Quality Manager.
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.
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
NOTES:
Additional Salary Information: Annual incentive plus comprehensive benefits program.
About EXO PPP, LLC
Human Capital Consulting Partners is a retained search firm that is working with EXO PPE, LLC on an exclusive basis to assist them in identifying, recruiting, and retaining top talent. HCC Partners is located in Trevose, PA.
