The Quality Engineer assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. Assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data. Jobs that provide engineering technical support in this field should be assigned to this job family.
PRIMARY DUTIES & RESPONSIBILITIES
- Identify and drive the resolution of internal quality issues.
- Utilize Corrective Action/Preventive Action (CAPA) process to improve and sustain quality improvements to the QMS and/or product.
- Utilize Supplier Corrective Action Request (SCAR) process to improve and sustain supplier quality.
- Perform/participate in Supplier, Internal, and 3rd Party Audits.
- Writing, execution, and review of Validation Protocols and Reports.
- Routinely compile and report key quality metrics data to multiple organizational levels.
- Lead routine Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials.
- Participate in site daily management and provide support in resolving quality related issues
- Ensure that the company’s products comply with the US Food and Drug Administration.
- (FDA), local and state agencies and the International agencies regulations.
- Performs other duties and task as assigned by supervisor/manager.
- Associates degree with 4 years of related experience in Quality OR
- BS in Engineering or similar discipline
- 3 to 5 years of Quality Assurance experience within an FDA regulated industry.
- Working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820).
- Applicable knowledge of Risk Management and Supplier Quality management.
- Experience in working within an ISO 13485 compliant Quality Management System.
- Understanding of EU MDR desired.
- Experience with root cause analysis, statistical technique, lean manufacturing, trending, Risk Management, and Six Sigma methodologies.
- Prior experience in Operations highly desired.
- Internal/Supplier auditing experience helpful.
- Experience with SAP desired.
- Excellent problem solving and presentation skills, as well as the ability to quickly learn a new environment.
- Cross functional experience with products, engineering processes and manufacturing processes to maintain credibility to communicate and influence change at all levels within the organization.