The Quality Engineer is responsible for designing and performing quality inspections, tests, quality system audits and experiments, as required, to evaluate risk, suitability of raw materials, components and finished goods overall quality to meet customer specifications and ISO 13485:2016 / FDA 21 CFR 820 Quality System and Regulatory requirements.
Performs inspections, evaluations, validations, and part layouts to defined criteria to evaluate product meets customer specifications as specified in Process Instruction Manuals or raw material inspection records, including but not limited to: incoming inspections, in-process and/or finished material/product to dimensional, functional, and/or visual criteria.
Solid knowledge in the usage of inspection, measurement and test equipment for dimensional verification, including application of GD&T and blueprint reading.
Leads and assists with performing CAPA root cause analysis of customer complaints and nonconforming material.
Places nonconforming material / product on quality hold at various stages of the manufacturing process according to procedure and notifies management of the incident.
Understands gamma radiation sterilization process requirements and assures sterilized goods follow control requirements during processing of the material / product.
Develops and executes process / product validations and PPAP documentation.
P.Q.P. knowledge in preparation / management of process flows, PFMEA's and control plans.
Supports and assists with assembly of Device Master Record documentation.
Assists as needed with gathering and analyzing quality data.
Assists with maintaining and auditing inspection / test equipment for compliance to calibration requirements.
Develops quality documentation, including work instructions, inspection records etc. to support Boyd Quality Management System.
Review Device History Records and finished goods release according to procedure.
Develop First Article Inspection procedures as needed.
Inspect and approve release of labels according to the Labeling Control Procedure.
Mentors Quality Auditors, Quality Technicians, and Quality Supervisor. Promotes Boyd Quality Management System throughout the production system.
Performs training and evaluates training effectiveness.
Complete customer surveys and questionnaires, as needed.
Understanding of the ISO 13485:2016 requirements. Will be an active participant in Customer, Registrar, and Regulatory audits.
Understanding of the requirements to maintain product identification and traceability.
Develop and enforce the cleanroom requirements for manufacturing personnel.
Follow cGMP practices and Environmental Control standards.
Perform other duties as assigned by the QA/RA Management and/or Executive Management.
Supplier development and quality system auditing as required.
Work overtime as needed by management.
Can report and/or correct any unsafe practice or condition.
Can stop any process and require nonconforming product to be quarantined.