Vacancy expired!
- Design Controls - Support Verification & Validation (test plans, protocols, reports), test method validation, Incoming Inspection, lot release of engineering, clinical and commercial devices, nonconforming product disposition, review of design documentation, calibration, and equipment validation (IQ/OQ/PQ)
- Clean Room, Environmental Monitoring - Establish plans and ensure ongoing compliance.
- Establish plans and ensure ongoing compliance with EO sterilization guidelines.
- CAPA - Participate with other team members in all aspects of Corrective and Preventive action process as required, including documentation of CAPA, root cause investigation, and implementation of improvement activities.
- Risk Management and complaint handling - Maintain the risk management file for Portal Instruments products throughout their lifecycle. Participate in complaint processing and failure investigations as needed.
- Supplier Management- Perform vendor audits and interact with vendors surrounding Supplier Corrective Action Requests (SCAR).
- Audits - Conduct and/or participate in internal and external audits as needed.
- B.S degree in Engineering, Science, or related discipline. Master's degree in engineering or MBA is a plus.
- Minimum 5 years' experience in a medical device environment. Preferably including design and manufacturing experience.
- Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971. Experience developing or modifying Quality Management Systems in accordance with these regulations is desired.
- Knowledge and experience with MDSAP, EU MDR, IEC 62304, ISO 60601 and clean rooms.
- The employee must exert up to 20lbs. occasionally, and/or up to 10lbs. of force frequently, and/or negligible amount of force constantly to move objects.
- Health insurance
- 401k
- Partial remote flexibility
- Potential to extend
Vacancy expired!