SUMMARY: Innovative, well-rounded Quality Management Professional with sixteen years of progressive leadership experience in high volume medical device and contract manufacturing. Core Competencies include: FDA: 21 CFR Part 820, Coordinate Corrective and Prevention Action System, Develop Training Programs, and 8-Step Problem Solving ISO 13485 Quality Management System, Quality Engineering Project Management, Effective Oral and Written Communication Skills Risk Management, ISO and FDA Site Inspection, Lean Manufacturing, Lead Auditing Training, Coordinate and Prioritize Multiple Tasks, Management Review, Budgeting, Mentoring and Team Development Specialties: auditing, budgeting, concise, customer satisfaction, directing, documentation, executive management, general management, ISO, leadership, leadership training, microsoft access, microsoft excel, microsoft office, microsoft outlook, microsoft powerpoint, packaging, policy analysis, process engineering, promotional materials, protocols, quality, research, risk management, strategic planning, validation

Quality Manager @ From December 2014 to Present (1 year) Plymouth, MNQuality Manager @ From 2014 to Present (1 year) Quality Managee @ From 2014 to 2015 (1 year) Sr. Quality Engineer @ From August 2013 to December 2014 (1 year 5 months) Sr. Quality Engineer @ From August 2013 to December 2014 (1 year 5 months) Quality Manager @ Managed a Quality Department of 51 with 11 direct reports 9-Quality Engineers, Supplier Quality Manager, and Inspection Supervisor. Collaborated with the Director of Quality to develop a quarterly Management Review format for the Chaska division. Led the development and implementation of a Risk based Corrective and Preventive Action (CAPA) program. Achieved a 25% reduction in non-conforming product by 4th Qtr 2010. Created a Corrective Action form modeled after the 8-step problem solving process. Worked as a change agent, refocusing the manufacturing and quality departments from rate based culture to a quality based culture. Implemented changes to quality reporting metrics, Management Review, PFMEA, non-conforming products, and CAPA processes. Set-up biweekly meeting with each of the Quality Engineers for updates on projects, to discuss current quality issues, and work on career path planning. Collaborated with the Manufacturing Manager’s on developing weekly, monthly, and quarterly trending charts. Collaborated with the packaging Quality Engineer on developing a process for the verification and control of labeling. Resulting in a significant reduction in complaints for mislabeled products. Implemented a peer group meeting with manufacturing, planning, and shipping/receiving which provides a better flow of information between the various departments. Created and executed under a tight timeline, a new work schedule for each of the inspection departments. LRM changed the manufacturing work schedule from the traditional 5 day work week to a 7 day work week. Championed a project in our hydrophilic division implementing SPC in-process monitoring of defects found during manufacturing, re-design of the pinch test system, certifying the pinch test operator, and adding in-processes auditors. Resulting in a reduction in customer complaints, decreased test failures, and reduction in in-process scrap. From October 2008 to February 2013 (4 years 5 months) Director of Quality and Regulatory @ Led the development of nine quality and failure analysis professionals and directed and developed all areas of Quality Assurance for two divisions located; Collaborated with the General Manager of Victoria Operations and the CEO of HEI on developing a strategic plan for quality that met the companies overall strategies. Evaluated each quality team member and developed a career path, leading to the promotion of two team members. Quality Management Representative for HEI Microelectronic and High Density Interconnect divisions. Cost saving of $165,000 realized by utilizing lean and 5 S to reorganize quality engineering and inspection increasing through put capacity by 15% and Failure Analysis capability by 35%. Evaluated and championed a team to develop documentation and processes to implement ISO 13485:2003. Collaborated with the executive team on five year strategic planning for HEI Microelectronic division. Created a validation format which incorporated validation master plan, control plans, and risk management to meet the requirements for medical device manufacturing (cGMP). From September 2006 to October 2008 (2 years 2 months) Director @ Led professional development of twenty-two quality team members and directed and developed all areas of Quality Assurance: policies, documentation, incoming and in-process inspection, final release, supplier quality, validation activities, Research and Development quality activities, audits, process improvements, and lean manufacturing. Collaborated with the Vice President of Quality and Regulatory on developing a strategic plan for quality that met the companies overall strategies. Cost saving of $200,000 realized by using lean and 5S to reorganize inspection and testing labs providing increased testing capacity without increasing staffing. Championed a multi-functional team that converted Minntech's Quality Management System to ISO 13485 resulting in certification from Minntech's notified body NSAI. Created a Risk Management format and coordinated the efforts to convert all of Minntech's CE mark products to meet the requirements of ISO 14971 (Risk Management Plan). Created a Management Review format that uses metrics and trending to provide Minntech's Executive Management team with a clear and concise picture of the effectiveness of Minntech's Quality Management System. Created a training program that provided an overview of applicable standards and regulations, including FDA, 21 CFR -Parts 820 and ISO 13485. Reduced customer complaints by 20% in a three year period by directing process and product improvements that directly impacted product reliability and increased customer satisfaction. Coordinated quality efforts for three new products that received 510K approval from the FDA by developing quality plans, quality engineering, and design phase activities meeting all project timelines and within budget requirements. Led the Auditing efforts at Minntech's overseas manufacturing plant. Audit facilitator in over 80 customer led audits. From January 2002 to July 2006 (4 years 7 months) Quality Manager/Engineer @ Led a team of nine professionals in Quality Assurance (six Chemist, two Microbiologist, and an Inspector) and provided quality-engineering support by writing and performing qualification/validation protocols for the production and laboratory areas that supported the Solution Division (hours of operation 24/7). Reduced laboratory turn around time from three days to 13 hours by reorganizing the work flow through the laboratory and integrating automated testing equipment that allowed the chemist to multi-task. Developed and validated, in a three week period an Access database that automatically performed the calculations and printed out a certificate of analysis freeing up 15% of the chemist time. The database also trended first time pass rates which identified improvement opportunities that led to an increase in the first time pass rates of 10%. Reduced inspection/testing time by 65% and increased production capacity by 15% by leading the validation effort for the Liquid Bicarbonate process. Qualified three new automated manufacturing processes. Reduced labor from 15 operators to seven operators and increased production capacity by 100%. Human error non-conformances decreased by 75%. Reduced overseas shipment complaints by 90%, by leading an effort to increase packaging integrity. Led the development of the Corrective and Preventive Action (CAPA) program. As a result Minntech reduced supplier issues by 50% and internal training issues by 85%. From January 1995 to January 2002 (7 years 1 month) Quality Supervisor/Engineer @ Led a team of four chemists in the quality Chemistry Laboratory which supported the Solutions Division. Developed and updated documentation for the laboratories. Analyzed and dissected problems using a variety of statistical and analytical tools. From January 1994 to January 1995 (1 year 1 month) Analytical Chemist / Laboratory Manager @ Managed the day to day operation of an Environmental testing laboratory. Increased revenue from $4,000 a month to over $90,000 a month over the course of four years. From January 1991 to January 1994 (3 years 1 month) Quality Engineer @ Collaborated with manufacturing engineering on developing designed experiments to trouble shoot production problems. Developed a tin plating process that eliminated lead from the process of plating printed circuit boards. From January 1987 to January 1991 (4 years 1 month)

Master of Business Administration, Management @ University of Saint Thomas - School of Business From 1998 to 2001 Bachelor of Science, Chemistry @ St. John's University From 1983 to 1987 Rick Tokar is skilled in: ISO 13485, CAPA, Process Validation, Risk Management, V&V, Medical Devices, FDA, SPC, Validation, Quality Assurance, ISO, Quality System, GMP, Design of Experiments, Quality Management, Lean Manufacturing, Quality Control, Supplier Quality, Manufacturing, 5S, Process Engineering, ISO 14971, Process Improvement, Manufacturing..., Testing, Design Control, Software Documentation, DMAIC, Failure Analysis, FMEA