Seaspine Irvine , CA 92606
Assures quality requirements are in compliance with FDA, ISO, EN, AATB, Canada and other national and international standards, as applicable. Provide QA technical support to operational areas (i.e. Manufacturing and Product Development) and Quality Assurance in order to ensure product quality and safety. Support/Coordinate the CAPA and Complaint program, as required. Interface with other departments to assure quality requirement are met. Conduct internal and external audits. Develop and execute product, process, and test method validations.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Perform standard engineering assignments which are typically a significant portion of a larger project. Select sound techniques to solve problems and make design recommendations under direction of supervisor. Assess results for application, validity and conformance to specifications. Recommend material and process specifications.
Use quality engineering tools to for problem solving (e.g. FMEA, SPC, DOE).
Analyzes complex production and quality trend data to identify and solve problems.
Support Risk Management activities for the HHE, Complaint and CAPA process.
Support for design controls.
Preside as a key quality participant in compliance audits and FDA inquiries.
Support post market activities such as complaint investigations, complaint trending, CAPA and FCA.
Lead small project teams as needed to accomplish project objectives.
Perform equipment and process qualifications/validations using IQ, OQ, PQ methodology.
Perform test method validations and Gauge R&R studies.
Manage and maintain the site Master Validation Plan(s).
Implement changes to products and manufacturing to improve quality and reliability and to address improvement of process, design, or materials.
Provide QA technical support in order to ensure compliance with FDA, ISO, EN, AATB, and other national and international standards, to assure product quality and safety.
Provide QA investigational support for product NCRs, CAPAs and Complaints.
Conduct risk management/risk assessment activities.
Participate in New Product Initiatives to ensure smooth transitions to production.
Manage and conduct both internal and external audits and qualify new suppliers and/or components.
Interface with Suppliers to review specifications, address supplier corrective actions and resolution of quality programs.
Work with the Calibration department on development of gauging, review and approve calibrations to requirements and conduct Out of Tolerance investigations.
Support the Quality Management System (e.g., facilitate change orders, CAPAs, Document Control, and Design Control System).