Provide quality engineering support for new product development teams, ongoing projects, and operations/production support. Maintain quality standards which adhere to the company's Quality System and international order to meet the company goals. Ensure the successful completion of individual projects and coordination of staff activities in order to meet the company goals. Manage and coordinate staff within the Quality Engineering group.
Oversee and provide quality engineering support for new product development projects and ongoing projects. Provide support to receiving inspection to develop test fixtures and methods as needed. At times, conduct facility area inspections in support of the Quality System. Provide support during outside facility audits and inspections. Act as second to site quality leader during audits and when site leader is not available.
Provide technical support for process validations (IQ/OQ/PQ). Ensure that validation plans are defined and carried out. Oversee the functions and operations of the Quality Engineering department.
Provide quality engineering technical support in the development and qualification of new designs and/or changes to existing products. Plan, schedule and complete projects in support of the company goals and objectives. Keep executive staff informed of any issues that adversely impact the Quality System. Support design control activities, including managing and conducting risk management reports.
Provide technical support for validation and verification activities of major design projects, line extensions, and minor device changes. Perform and oversee complaint and NCMR failure investigations. Manage CAPA system to ensure adequate CAPAs are opened and closed in a timely manner. Interact with outside suppliers and vendors to ensure quality goals and standards are met.
Mentor, lead, and performance review of Quality Engineering staff.
Participate in resource planning, recruiting, and budgeting. Attend project meetings and establish activity timelines to meet department and company Goals and Objectives.
Prioritizes supports and facilitates the workload to Senior Quality Engineers, Quality Engineers, Assocate Quality Engineers, and Quality Engineering technicians within their Value Stream or Work Stream.
Reviews and Authorizes Engineering Change Orders, Manufacturing Change Orders, Source of Supply, Control Plans, PFMEA's, SOP and Procedure change requests. Reviews non-conformance investigations and corrective actions.
Work with manufacturing engineers to implement risk analysis, manufacturing control plans, and inspection plans for in-process and final inspection.
Supports FDA and ISO 13485 inspections/audits. Creates and updates SOP's, WI and forms as required.
Performs inspections as needed, or ensures that inspections are performed by qualified personnel and that inspection results and documentation support the recommended disposition action.
Evaluate and qualify manufacturing processes to ensure technical requirements can be met. (MSA, Cpk, assembly validation, etc) Provide process development and operations with inspection criteria prior to manufacturing.