Sr. Quality Engineer
Proclinical is currently recruiting for a Senior Quality Engineer with a leading medical technology and device company located in Allentown, PA. Successful candidate will assist in the assembly of technical files for the FDA, and other Regulatory Bodies, as applicable.
- Maintain Quality Recall Dashboard metrics for input into Management Reviews.
- Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
- Coordinate, and monitor FDA vigilance notifications and recall activities.
- Act as the Quality representative for communication and interfacing with the FDA regarding Field Safety Notice and Recall Notifications.
- Coordinate and organize Site Corrections and Removals (recalls). Expedite the coordination of activities for timely FDA reporting and interface with Supply Chain, Marketing, and Product Managers.
- Lead Health Hazard Assessment (HHA) and Health Hazard Evaluation (HHE) activities with collaboration from Regulatory Affairs, Product Managers, R&D Engineers, and the applicable OEM as part of company Risk Management Program.
- Ensure corrections, removals and recalls are managed effectively and efficiently.
- Support decision making for Health Hazzard Assessments, Vigilance Reporting, CAPA, and Recall based on analysis and trending of post-market data sources.
- Assist with onsite ISO and FDA inspections and maintenance of formal responses to findings.
- Coordinate, monitor, and analyze trending of Recall data for Monthly Quality Data Review and Management Review Meeting (MRM) discussion.
- Act as the lead and mentor for guidance on Corrections and Removal (Recalls).
- Ability to process complaints and MDRs as needed.
- Coordinate and monitor FDA vigilance notifications, recalls and Health Risk Assessment (HRA) and Health Hazard Evaluation (HHE) activities.
- Act as the Quality representative for communication with the FDA regarding Field Safety Notice, Recall Notifications and inventory recovery reconciliation.
Skills and Requirements:
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual.
- Must embody the Company's Vision, Mission and Values.
- Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.