Steve Lardner Email & Phone Number

Northfield, Il

Directs and oversees the development and operation of CAP performance excellence and quality management systems consistent with ISO and service industry best practices. Responsible for managing internal quality/performance improvement plans through collaboration with CAP management team and staff to support integration into CAP operations including development of detailed specifications for systems related requirements, policies, processes, and procedures.Primary responsibility for leading CAP quality and performance improvement initiatives and change management consulting services to departments to facilitate CAP’s shift to a culture of continuous quality/performance improvement, enhance operational efficiency, client, staff and peer participant satisfaction, and accreditation program integrity.Also responsible for leading development and integration of CAP program quality management systems approach into requirements and customer quality trends.Developed and implemented the QMS leading to successful accreditation to ISO/IEC 17043:2010 Conformity assessment -- General requirements for proficiency testing

Lead and managed the ISO 9001 Quality Management System (QMS) for an FDA registered medical device manufacturer: Responsible for Internal Audit, Corrective Action/Preventive Action (CAPA), Document Control, Customer Complaint programs, FDA Regulatory Affairs.No major non-conformances in ISO or FDA audits from 2006-2008.Guided product, process and continuous improvement efforts that achieved Quality and On-Time-Delivery (OTD) objectives in 2006 and 2007. Corrective Action System: Ensured timely and thorough root-cause-analysis (RCA) and corrective action, reducing CAR response time by 57% and "recurring" problems by 50%Initiated development and implementation of balanced scorecard metrics (BSC) for the quality dept. and assisted VP of Ops with similar metrics for other functions in Operations.Lead Customer Complaints Team weekly meetings, reviewing complaints for MDR reportable events, follow up investigation, complaint trending.

Planned, developed, implemented and achieved quality management system certifications for ISO 9001 and QS 9000 TE Supplement and then managed them.Served as Managment Representative for Quality, Lead Internal Audits, Managed CAPA (corrective/preventive action) program, Developed and conducted statistical process control (SPC); Design of Experiments (DOE), machine process capability (Cpk) and gauge repeatability and reproducibility (GRR) studies to identify critical factors affecting machine capability

Managed gage calibration program, performed GRR, Cpk and MSA studies for PPAP's and prepared PPAP submissions for automotive customers, e.g., Ford, Chrysler, etc.Participated in design and production FMEA's and initiated production process improvements.

Mba, Information Systems

Education record