The Quality Assurance Engineer ensures compliance to existing procedures and regulations through document review, audits and facilitation of risk management, data trending and root cause analysis.
- Analyzes production limitations and problems and facilitates root cause analysis.
- Analyzes data to bring conclusion to production and quality management.
- Reviews change orders for product releases/updates and production material and process changes.
- Conducts and documents internal non-conformance and customer complaint investigations.
- Support in Medical Device reporting (MDRs), complaints, field corrective action (Recall) and management review meeting
- Effectively engage in project as the Quality Engineering resource.
- Formulates or assists in formulating quality standards, policies, programs, plans, procedures, and practices. Assesses and approves product and process validation activities.
- Performs such individual assignments as supervisors and superiors may direct.
- Ensures adequate and continuous controls are exercised over all assigned activities affecting quality.
- Establishes and maintains effective work relationships.
- Maintains the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities.
- Facilitates the completion of Risk Analysis documentation for new and existing products/processes.
- Organize and conduct internal and supplier audits.
- Initiates and manages Corrective/Preventative actions based on data review and input from outside sources and internal data analytics.
- Serves as quality contact during customer and notified body audits