Stephanie Rutter Email & Phone Number

Stony Point, NC

Morganton, NC

*Obtained ISO 15378 certification for three North American facilities through learning the standard, organizing and facilitating multi-site preparation meetings, developing FMEA, determining gaps, and tracking action items to completion.*Streamlined quality system documentation through new document format development and redundancy elimination. The.

• Supervised document control, incoming inspection, control of nonconforming product, calibration, internal audit, and training coordination processes and personnel.
• Led quality team through facility shutdown and ensured no major downtime for quality related issues during the transition period.
• Streamlined level 1 and level 2 process documentation through new document format development and process owner identification and engagement. The new document format is now being rolled out to other CCS facilities.
• Improved organizational perception of and support of the quality department through formation of Product Quality Support Teams and modeling desired behaviors.
• Improved quarantine event organization, communication, and duration through development of a quarantine event checklist.
• Kept plant management informed of quality metric status by preparing and leading quality management system top management reviews.

• Increased operator use of standard operating procedures from rarely to daily by reducing standard operating procedure volume by 80% without losing content, eliminating redundancy, and correcting errors.
• Improved AS9100 compliance by 52% and maintained certification through developing quality management system processes and engaging process owners.
• Obtained EASA Part 21-G and FAR 145 certifications through learning the regulations and integrating requirements into existing systems.
• Decreased document approval time from weeks to days and increased document availability to the general population by researching, justifying, purchasing, & implementing document control software.
• Promoted quality management system awareness through development of new hire orientation and fun and engaging annual refreshers.
• Developed a cross-functional team of >10 internal auditors and achieved the annual internal audit schedule and promoted standard awareness throughout the organization by creating and promoting an internal auditor.

• Developed new technologies including design of experiments, process and equipment optimization, contingency planning, and risk analysis.
• Communicated status and recommended courses of action to a multifunctional, multinational team.
• Managed project schedule including maximizing learning, prioritizing, daily planning, and multiple project coordination.
• Improved analytical laboratory process including methods development, data reporting, and personnel training.
• Identified process control strategies including centerlines and control levers.
• Worked in a global team environment.

• Responsible for technical aspects of several manufacturing areas.
• Justified and purchased equipment.
• Documented processes in an ISO-9001 and FDA regulated environment.
• Performed risk and failure mode analyses.
• Supervised a team of operation personnel ensuring safety and productivity.
• Utilized Statistical Process Control to manage manufacturing area.

Bs, Mechanical Engineering

Activities and Societies: • Minor in mathematics. • Recipient of Dean's scholarship. • Treasurer of the Society of Women Engineers.

Education record