Designation: Quality Engineer
Minimum degree requirement is a Bachelor’s in Industrial Engineering or a closely related field.
- Review and assess the completeness of the internal and supplier’s First Article Inspection (FAI) requirements against the product specification and drawings requirements.
- Responsible for conducting gap analysis of the products to align with current regulations. Reviewing and updating existing procedures, part qualification documents, supplier qualification documents with respect to FDA regulations.
- Develop inspection plans incorporating the implementation of statistical sampling plans and tools for medical devices like patient monitors, defibrillators, aspirators, and vials to ensure materials conform to specified requirements.
- Performing root cause analysis, taking corrective actions, containment activities for several major finding while internal quality audits (CFR 820.22 and ISO 13485), CAPA (21CFR 820.100), NCR (21CFR 820.90) procedures.
- Review Incoming Inspection data to ensure received product manufactured according to specifications pertaining to functionality and safety of patient.
- Coordinate with suppliers in completing failure investigations to identify the potential root causes of the nonconformance and escalating the non-conformance and gap analysis results with supplier and other cross function team to have appropriate and cost-effective solutions.
- Evaluate the need for process improvement based on the Nonconformance data. Analyze the complaints file to identify the top defective parts and evaluate actions required to eliminate those defective parts.
- Performing Gage R&Rs on modified test methods and analyze the data for conformance with the applicable requirements and specifications using tools like MS Excel & Minitab.
- Initiate Engineering change orders (ECO) to implement the changes required for implementing the correct inspection requirements for the medical devices.
- Identify CTQ (Critical to Quality) characteristics and create Quality plans to determine COC (Certificate of Conformance)/ COA (Certificate of Analysis) requirements.
- Author, approve and audit the controlled documents based on 21 CFR Part 820 guidelines. Review the risk management of the product using ISO 13485 & 14971 guidelines.
- Periodically review issues by tracking database to verify issues are being resolved and closed in a timely manner in accordance to corporate policies and FDA regulations.