Ronald L. Bate

*** ******** ***** *********, **** 44095

440-***-**** acesof@r.postjobfree.com

Experienced Manager Continuous Improvement ? Organizational Design

and Development

A highly experienced and accomplished leader with profit and loss

responsibility as well as broad-based expertise in quality assurance,

regulatory affairs, operations analysis, project management, loss

reduction, cycle time reduction, production planning, new product

introduction, Six Sigma, Kaizen, ISO 9000, ISO 13485 and AS 9100

certification, FAA regulations, FDA regulations, Medicare/Medicaid

compliance, strategic planning, business development, validations, and

system engineering. Leads diverse teams to reach new levels of

success and to provide solutions in a highly competitive and fast-

paced environment. Combines strong technical and business acumen to

achieve the long-term objectives of an organization. Seizes

opportunities to develop innovative and cost-effective solutions for

enhancing competitiveness, increasing revenues, and improving customer

service offerings.

Experience

AMRESCO, LLC, Solon, Ohio

Director of Regulatory Affairs, Compliance 2013- Current

Responsible for oversight of global regulatory affairs activities. Design,

planned and executed business-aligned strategies for customer regulatory

submissions in close collaboration with marketing, research and

development, manufacturing, and sales partners for optimum achievement of

corporate objectives. Manage and mentor regulatory affairs staff. Provide

regulatory advice to other departments and Executive Management. Provide

expertise in the interpretation of regulations into practical and workable

plans. Review and interpret existing or new external standards and

regulatory requirements as they relate to AMRESCO, LLC products and

processes. Leveraging internal and external supply chain to drive product

improvement. Coordinate risk-balanced regulatory strategic direction and

provide advice, with contingencies, to project teams and Executive

Management to assure that regulatory requirements are incorporated into

development processes. Primary liaison with regulatory agencies. Provide

regulatory strategic focus for life cycle management of internal and

supplier provided validated product and processes. Lead the regulatory

working team and represent the team at the global project team level to

ensure global regulatory lifecycle management strategy and planning is

written and executed according to plan. Responsible for managing all

aspects of internal and supplier quality compliance relevant to the

manufacture and release of products; reviewing and approving plans,

protocols and documentation associated with facility and equipment

validation and qualification; approving Maintenance, Engineering, and

Manufacturing SOPs, including Master Batch Procedures; reviewing batch

records and providing final release approval or rejection of all products;

approving all process and operational changes; and coordinating cGMP

training. Coordinated customer complaint files and databases in accordance

with FDA and other regulatory requirements.

National Biological Corporation, Beachwood, Ohio

Director of Regulatory Affairs, Compliance, Quality, and Engineering

2008- 2012

Responsible for submission and compliance of company's products for US,

Canada, China, Japan, EU, and worldwide regulatory approval/clearance,

import/export clearance, safety and effectiveness. Review for technical

support and completeness of 510(k) s, Technical Files, etc. Advise

improvements to comply with current requirements for different country

regulatory authorities. Responsible for 510(K) submissions and FDA

registration, Canada, China, Japan, EU medical device registration.

Worldwide market approval/clearance. Develop global regulatory strategies

for current products and to deliver quality services to those customers.

Communicate regulatory requirements and strategies to management board for

product transition including product development through qualification

testing and submission/registration. Review all labeling, promotional

literature, sales brochures and technical documentation to ensure that

label formats, instructions, literature and any claims to be published are

accurate and consistent with cleared indications for use, product design

documentation, and appropriate international and domestic regulations.

Coordinate design and product development. Provide solutions and technical

assistance to the team in developing validation test protocols for

compliance with industry standards and FDA guidance documents. Management

of Engineering department personnel (Project Engineers, Designers, and

Technical Draftsmen) including monitoring work produced, teaching/training,

and professional development. Oversee and review proposals, estimates,

design concepts and drawings, calculations, specifications and safety

standards. Coordinate board reviews and formal design checks. Provided for

a supplier controls program that included ratings and scorecards.

Direct organization as Compliance Officer to maintain; domestic and

international regulatory compliance, negotiate distributor agreements,

product registrations, obtain Certificates of Foreign Government. Promote

the organizations awareness of domestic and international regulatory issue

and concerns. Ensure compliance with Medicare and Medicaid guidelines.

Recommend and influence action in direct response to new and proposed

domestic and international regulations.

Working with and assist with the Customer Service Team to resolve customer

problems and complaints. Support marketing efforts by making customer

(home, doctor, and hospital) calls and preparing technical proposals.

Coordinate customer feedback and other considerations into new product

designs.

Trust Technologies and Miltronics & Skye (subsidiary of trust

technologies), Mentor, Ohio

Operations Manager (Combined operations) 1997-2008

Operations management and complete P&L responsibility for product

manufacturing in the industrial gas turbine and medical device fields.

Consistently exceeded sales quotas and delivered significant strategic

marketing planning. Selected, interviewed, and hired personnel for all

levels of the organization. Served as the primary responsibility for

hiring, employee disciplinary actions, Oversaw research and operations of

manufacturing support activities with excellent results in terms of

streamlined productivity. Ensured compliance with all safety, quality, and

industry standards as well as with FDA Regulatory, OSHA, company, and other

governmental rules, regulations, and guidelines. Built and maintained key

client accounts some of which include Stryker, Johnson & Johnson, Parker

Hannifin, Woodward Governor Groups. Prepared written agendas, summaries,

and action plans for review during monthly sales and operations meeting.

Oversaw new- product introduction, including initial program planning,

operational review, and program closure meetings, and supplier selection

and controls to ensure compliance with all customer and contract

requirements using APQP, PPAP, and phase gate introduction process. Worked

closely with the quality team on implementation and use of lean and quality

tools such as Kaizen events, root-cause analysis, 8D corrective action,

value-stream mapping, and other lean activities.

. Effectively governed the organization and implemented innovative

production and marketing strategies; affecting an increase of $3.3M in

annual sales in 2007. - Personally increased profit margins from 7.75%

to 13.7%.

. Key player in successfully increasing manufacturing space from 32,000 to

54.000 square feet.

. Contributed comprehensive operational and organizational knowledge and

business management expertise in developing and executing the Quality

driven strategic business plan.

Operations Manager (Miltronics & Skye (subsidiary of trust

technologies), Mentor, Ohio) 2005-2006

Worked closely with HR to assess employee needs and training. Managed and

coordinated work requirements for 59 employees, including review of work

performance and providing motivation for a more effective work force, as

well as identifying and resolving work-performance issues. Collaborated

with production planning on scheduling machines and employees. Partnered

with management team members on creating yearly budget. Monitored and

evaluated expenditures, including approvals. Held P&L responsibility.

Performed personnel administrative tasks, including coordinating and

participating in hiring and promotion process, contributing to orientation

of new employees, resolving employee problems, and managing employee time

and attendance.

Conducted meetings to exchange information and discuss methods to improve

organizational effectiveness. Prepared written agendas, summaries, and

action plans for review during monthly sales and operations meeting.

Oversaw new- product introduction, including initial program planning,

operational review, and program closure meetings, to ensure compliance with

all customer and contract requirements. Worked closely with the quality

team on implementation and use of lean and quality tools such as Kaizen

events, root-cause analysis, 8D corrective action, value-stream mapping,

and 5S. Monitored cost of poor quality and led initiatives to reduce this

key metric on continuous basis.

. Improved inventory record accuracy, eliminating annual inventory losses

exceeding $200,000 and improving record accuracy by 63%.

. Created saw-cut calculations for raw bar stock to reduce material

consumption 12%, saving $145,000 annually. Achieved cycle-time

reduction of 27% on high-volume program, resulting in annual savings of

$49,000.

. Led initiative to increase internal on-time delivery metric from 56% to

94% in six months through improved workflow, scheduling improvements,

and 5S.

. Reduced wait and staging time between departments with Kaizen event to

move machines and people for increased flow and coordination between

teams.

. Improved scheduling and workflow to reduce reliance on overtime by 27%

in first year and 33% in second year.

. Led cross-functional TQC teams and coached team members to develop

skills and confidence.

. Participated in management team process to develop vision and mission

statements.

Director of Quality (TRUST TECHNOLOGIES) 2002-2005

Held quality management responsibilities. Transitioned ISO 9000 quality

management system to new registrar. Learned medical business requirements

and trained organization on requirements. Took responsibility for

regulatory compliance initiatives, including interfacing with FDA and

understanding FDA's GMP and 21 CFR 820 requirements. Review and

coordination of any reporting for adverse event reports. Development of

510(k) for contracted work of implantable devices.

. Designed and implemented of quality program in accordance with FDA GMP

requirements.

. Coordinated the implementation of ISO 13485.

. Coordinated the Validation program including the development of

protocols and IQ/OQ/PQ's as needed.

Quality Assurance Manager (TRUST TECHNOLOGIES) 1997-2002

Developed and implemented ISO 9000, AS9100, FAA Repairs Station quality

management systems. Coordinated internal and external audits, as well as

customer and registration audits. Developed and implemented

production standards and organizational best practices. Coordinated the

evaluation and reporting of quality and reliability information to internal

stakeholders. Developed training programs for all employees, including

management of quality assurance theory, practices, processes and design,

statistical data controls, sampling procedures, and corrective action.

Formulated sampling procedures and designs, including forms and

instructions, for recording, evaluating, and reporting of quality-related

statistical data. Analyzed non-conformance data and created reports to

detect trending of production problems. Investigated customer concerns and

complaints for continuous improvement and to reduce risk of further escapes

to customers.

. Standardized and created quality plans, work instructions, and

procedures to meet customer specifications.

. Created MRB and quality review board.

. Achieved annual savings of $147,250 by championing Six Sigma team on

three projects.

. Implemented RMA process, reducing response time on complaints from 82

days to nine with action plans.

. Instituted and trained 5S in all areas, focusing on product flow.

. Completed three Kaizen events, increasing utilization of four machines

from 36% capacity and three days of wait time to 78% capacity and four

hours of wait time, as well as realizing 8,000 square feet of under-

utilized floor space.

Additional Experience

Jerpbak/Bayless Company, Solon, Ohio, Quality Assurance Manager, 1993-

1997. Initiated quality program based on ISO 9000 and NRC 10CFR50

principles. Updated and developed procedures in preparation for ISO

9000 certification. Served as quality and engineering manager

responsible for quality program and one engineer-programmer.

Introduced and trained personnel in use of Statistical Process Control

(SPC). Functioned as customer liaison for Marine Mechanical and

interfaced with customer's quality, engineering, and technical staffs

in developing new programs in the Nuclear Propulsion industry.

Pace Engineering, Willoughby, Ohio, General Manager, Product Manager,

1990-1992. Managed and directed electro-mechanical test, handling

equipment production for MK 48 ADCAP torpedo program in coordination

with Westinghouse in Euclid and Hughes Aircraft in Los Angles.

Negotiated order for 150 cable assemblies for Picker X-Ray.

Established sole source on one component for Mk 48 Torpedo assembly

and testing line, generating $176,000 in year-over-year sales.

Negotiated supplier contracts with welding house, fiberglass, plating,

and painting houses. Implemented heat treat line for components of

the off-road earth-moving equipment line, saving over $275,000 in

outside heat-treat costs.

Pace Engineering, Willoughby, Ohio, Quality Manager, 1987-1990.

Directed quality activities and strategies. Implemented ISO 9002

business development plans, quality Improvement projects, and

generation of procedures in support of activities. Oversaw management

of company's military quality program (Mil-I-45208). Initiated gage

management and calibration program, saving thousands of dollars in

excess costs. Oversaw all aspects of new product introduction.

Pace Engineering, Willoughby, Ohio, Machinist, 1986-1987. Served as

machinist in milling department. Set up and machined product to

blueprints and specifications.

Education

Cleveland State University, Cleveland, Ohio, B.B.A.

Cleveland State University, Cleveland, Ohio, M.B.A.

professional development

Managerial Skill Development

FDA Quality System Regulation, Requirements and Industry Practice

Lean Manufacturing

University of Tennessee - Lean Manufacturing

Air Academy - Certified Six Sigma Champion

Member of AAMI, Regulatory Affairs Professional Society (RAPS)

computer skills

Excel, PowerPoint, Word, Minitab

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