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Director Of Regulatory Affairs Resumes in Indiana

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1.
M Randall
Location: Indianapolis, IN 46231
... rs of progressive, broad-based quality and reliability engineering and management experience. Strong quality orientation, cross-technology expertise, and distributed project management capabilities. Excellent written and verbal communications skills. Adept at collaborating with diverse product design and operational groups. Proven ability to drive best in class business practices to achieve low cost, high quality products. Career has been marked by enhanced operation and cost efficiencies, product/service quality improvement, productivity, internal/externa l customer satisfaction. A decisive, proactive self-starter with proven technical, analytical, problem-solving, interpersonal and commu ...

97 hits
2.
D Tunink
Location: Carmel, IN 46033
... nagement skills, and IT management skills. Proven ability to build strong relationships with staff and clients using negotiation talent, persuasion and demonstrated commitment. Strong leader creating cohesiveness within teams, and motivational skills to drive results in team performance above individual ability levels, consistently surpassing expectations.Dri ves quality in systems by listening to customers' requirements and implementing solutions to satisfy those requirements.Com pleted projects saving over $2MM to company's bottom line. Experienced in establishing new operational procedures and policies to improve productivity, increase efficiency, and save money.Effectivel y utilized pro ...

95 hits
3.
K Osborn
Location: Lafayette, IN 47904
... ams / Not-for-profit Volunteer Industries: Manufacturing / Government / Construction / Retail / Financial Services Certified Quality Manager / Organization Excellence Process Control Engineer FMEA Documentation Contract Negotiations Internal Auditor Course Manufacturing Operations Certified Quality Auditor Product Development Laboratory Inspections Safety Focused New Business Startup Relationship Builder Corporate Training Policies & Procedures Military Experience Professional Activities & Affiliations Licensed Foster Parents ¨ Youth Soccer Coach ¨ May Day Bicycle Parade Coordinator Lafayette American Society for Quality (ASQ) Board Membership Ch ...

93 hits
4.
D Matthews
Location: Columbus, IN 47201
... esults oriented with over 25 years of domestic and international leadership experience in Quality, Manufacturing, IT, HR, Supplier Management, Engineering and Business/Financi al Analysis & Auditing. Experience includes: new facility startups & expansions, production process development and implementations, new product introduction , APQP, development/rede sign and implementation of Quality / Environmental Management systems Supply Base Management & improvement ISO/QS/TS auditing, implementation, maintenance in USA and internationally. Proficient in process automation, IT project leadership and management of capital expenditures, continuous improvement Experie ...

91 hits
5.
M Morris
Location: Indianapolis, IN 46236
... , along with the diversity of the industries for which I have worked. Experience Quality Engineer 10/2006 to Present The Phoenix Group Sub-assembly of engine components, warehousing and logistics, and component repackaging · Led the effort in obtaining ISO/TS16949 certification · Update FMEAs, Control Plans, Work Instructions following process improvements or quality issues · Implement assembly line improvements in terms of efficiency and quality · Performed Gage R&R and Capability Studies to ensure measuring tool effectiveness · Perform internal process audits and ensure compliance to internal and ISO/TS16949 requirements · Manage and measure the effectiv ...

89 hits
6.
C Risotti
Location: Indianapolis, IN 46237
... loping and implementing strategic planning, budgeting, and staffing. · Over 10 years in Information Technology in a regulated industry with formal SDLC practices. · Experience in developing and implementing formal SDLC processes. · Experience in auditing internally, and serving as the IT audit representative for client and FDA audits. · Experience in all GXPs. · Experienced in building departments and staffing. · Experienced in Process Improvement initiatives and implementations. · Experienced trainer for IT systems, GXPs, regulatory compliance. · Experience in Root Cause Analysis and Issue Tracking to resolution. ACHIEVEMENTS · Developed and implemented a form ...

87 hits
7.
A Tatum
Location: Gary, IN 46407
... e, long hours including daytime, evening, weekends and holidays and can work open to close. I plan to demonstrate high quality service techniques, including excellent customer service. Abilities My abilities are assisting in overall operation and performance of a store, which includes sales, merchandising, operations, and supervision, training and development, loss prevention, expense control and adherence to all company guidelines and procedures to ensure efficient daily operations. My primary job function is to assist the Store Manager, or act as the Store Manager in that person's absence. I ensure success of their store by creating an environment conducive for customers to fulfill their ...

85 hits
8.
R Leiber
Location: Indianapolis, IN 46236
... harmaceutical and laboratory industries can be utilized. Looking for a company that has a strong focus on quality and continual improvement.Curr ent duties include managing the entire quality system of a contract laboratory and performing quality system audits for the medical device and pharmaceutical industries.Over 6 direct years experience as a quality systems manager.Ball State University, 2001Current salary is 60,000 to 70,000 USD.Salary Expectation is 70,000 USDBenefits package expectation is Medical and Dental, more would be appreciated but not required.I am willing to travel.Do not speak a foreign language. References:Josh GloverComplaint HandlerWelch AllynRelation: Previous Colle ...

83 hits
9.
G Calafactor
Location: South Bend, IN 46613
... transition more than 25 years of professional experience in a government, consulting, and industry environment, into a new position utilizing my analytical, communication and creative skills in the areas of domestic and international medical device consulting, compliance, and regulatory, including contract positions at medical device companies and/or permanent positions at medical device consulting companies.SUMMAR YA Self-starter with good written and oral communications skills and over 25 years of professional experience as a level II certified international medical device investigator in the US government or as a contract consultant and regulatory compliance auditor in the medical device ...

81 hits
10.
J Hoover
Location: Wakarusa, IN 46573
... experience and business education to promote company and personal goals and growth. MANAGEMENT STYLE · Team-oriented, hands-on manager focused on maximizing all team member contributions for the greatest organizational success and team satisfaction. · Excellent communication skills, especially listening to and understanding others' proposals regardless of personal preference. · Excellent analytical abilities, capable of evaluating situations, determining root causes and resolving issues. ACHIEVEMENTS · Managed the design of the first recreational vehicle flexible drainage system used in slide-out kitchens. · Managed the transition of company-wide Canadian product listings fro ...

79 hits
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