Rita Stepp, Asq Cqa Email & Phone Number

Columbus, Ohio Area

The World Conference on Quality and Improvement is ASQ’s flagship conference. Join a broad attendee base representing a wide array of industries and over 45 countries from around the world to gain knowledge, improvement methodologies, quality tools, best practices, and network. The ASQ Section 801 serves Columbus and Central Ohio members in promoting excellence by providing education in continuous quality improvement.• Served as 2019 Site Committee volunteer for ASQ World Conference in Fort Worth, TX. Assisted in directing and answering questions for more than 2500 participants. • Participated on 2019 Spring Conference committee. Registered over 150 participants, proofread 32 pages of Marketing Program and compiled event budget. • Participated on 2022 Fall Conference committee. Registered 130 participants, proofread 30 pages of Marketing Program and compiled several process documents.

Columbus, Ohio Area

Provided leadership in the complaint investigation/closure processes, including coordination of sample testing, complaint file documentation, timely identification of trends, and alerted upper management of potential heightened situations. Facilitated projects to establish best practices and streamlined approach. Participated in validation of complaint and CAPA databases (TrackWise).• Interfaced with international/domestic affiliates and Third Party Manufacturing (TPM) sites to acquire complaint data. Closed 99% of complaints within targeted cycle time, attaining a critical monthly key performance indicator (KPI). • Expedited audits with regulatory agencies and Abbott Quality and Regulatory (AQR). Served in front room for FDA Infant Formula Act annual audits, with ZERO observations for past 5 years.• Alerted Global Product Protection of 12 potential tampering issues identified during customer sample testing, safeguarding customer brand.• Initiated a capacity model and utilized Greenbelt certification to implement 26 process improvements within 45 days, absorbing reduction of 6 headcount.• Organized successful “Complaint Lab Move”, attaining project milestones and a 50% space reduction. • Created 28 essential Trackwise queries and 18 visual job aids and provided design requirements for 9 business-critical reports, enhancing Trackwise complaint database implementation.• Spearheaded complaint coding gap analysis and developed a global coding guideline, establishing best practice.• Designed and facilitated 10 ABTRAQ (new CAPA database) training sessions, meeting aggressive training project goal.

Columbus, Ohio Area

Guided the production areas for both the Pump Service Center (PSC) and Device Manufacturing Center (DMC) plants to construct high quality medical device products, meet customer demand, attain financial stewardship, and improve employee training programs, while ensuring compliance with all FDA, ISO, and OSHA requirements. • Led a multi-tiered organization of greater than 60 employees.• Met 100% production-to-schedule for the DMC facility and 100% production-to-forecast for the PSC receiving, prep, board repair, and manufacturing areas for a five-year period, improving customer satisfaction.• Responsible for developing and managing payroll and direct expenses in excess of $5MM. • Removed $211K in labor expense from the DMC budget by establishing accurate labor standards. Reduced $33K in DMC material usage and $60K in DMC labor expenses by auditing planning system (AMAPS) and utilizing previous financial skills.• Directed the “DMC Facility Move” project, which delivered $225K (reduction of two headcount) and $170K (reduction in excess capacity), improving margin profitability.• Functioned as a medical device business Subject Matter Expert (SME) during the 2008 CAPA Certification Assessment validation process.• Developed a pump technical training curriculum for 28 Device and Quality Engineers, Project Leaders, Purchasing, and PSC management teams, increasing product knowledge.

Columbus, Ohio Area

Led the enteral feeding pump manufacturing and repair areas to meet/exceed productivity, safety, employee relations, and quality goals, while adhering to Division, Corporate, and FDA regulations, policies and procedures. Administered all facets of verification testing and technical training within the plant and the customer demonstration program.• Attained a 67% reduction in employee related exception reports, enhancing product quality.• Finalized 34 performance reviews and employee development plans, resulting in 9 talent promotions.• Organized project to revamp Customer and Biomedical Repair Training program, aligning with corporate legal obligations.

Bachelor Of Science - Business Administration, Minor In Hr, Summa Cum Laude

Certificate, Medical Coding And Billing Specialist

Activities and Societies: -Member of the Delta Epsilon Tau International Honor Society; March 2019-Graduates apply theory and practical.