LOUISVILLE SECTION PLACEMENT Job Listings For more information and Job Opportunities, please contact our Placement Chair, Mr. Michael Waterman at michael.waterman@jhsmh.org LOUISVILLE SECTION POSITION LISTINGS: Director of Operations (added 11/24/2007) Position (Title): Director of Operations Location: Mount Prospect, IL Company: Zingaro & Company: Executive Recruiting and Consulting Contact name: Tracy Wolfe, PHR Work Phone / Ext.:  (512) 327-7277 Fax: 512-327-1774 Email: twolfe@zingaro.com Position Summary This position, which is located in Mount Prospect, IL, reports to the acting Director of Operations. Your basic role is to run the daily operations and deliver projects within the agreed specifications and timeline. Additional responsibilities include: Overseeing and ensuring appropriate validation activities. Taking responsibility for business financials and site performance against financial plan. Planning for growth of the business. Ensuring the development of staff. Candidate Requirements We seek a seasoned operations and logistics professional with a minimum of 8-10 years of clinical trial packaging and supply experience. Prior experience supporting large global clinical trials is preferred. Candidates should have solid industry and operational experience within the pharmaceutical/contract packaging environment. For the best fit, you must be customer service focused, possess drive and motivation and a “roll your sleeves up” mentality. You must be dedicated to the success of the business, a strong team player, capable of working collaboratively with colleagues in all functions and have developed and provided effective leadership for a successful and well-respected distribution organization. Sr. Supplier Engineer: Medical Device (added 11/24/2007) Position (Title):Sr. Supplier Engineer: Medical Device Location: Cranston, Rhode Island Company: Preferred Professional Recruiters Contact name: Tracy Wolfe, PHR Work Phone / Ext. :512-327-7277 Fax :512-327-1774 Email: twolfe@zingaro.com Company Summary A leader in the medical products industry with more than a century of quality service to its customers, focusing its business on innovative products in key surgical specialties, including hernia repair, hemostasis, orthopaedics and laparoscopy.   Position Summary This position, located at company headquarters in Cranston, Rhode Island, reports to the Supplier Quality Assurance Manager. Your basic role is to work with assigned suppliers to implement the requirements of the supplier quality management program. Your duties include: Auditing, monitoring, evaluating, reporting and improving supplier quality system performance and providing technical support to suppliers. As required, coordinating component and product quality testing for purposes of supplier qualification and improvement. As requested and approved, coordinating with other Divisions to perform quality assessments on common suppliers to minimize costs and burden on the suppliers. Candidate Requirements Bachelor’s Degree required in Engineering or other technical discipline required. Minimum of three years experience in a supplier quality/supplier auditing capacity or equivalent preferred. Demonstrated ability to apply statistical quality engineering tools in a supplier environment. Continuous Improvement Coordinator (added 10/26/2007) Position Title: Continuous Improvement Coordinator Location: NE Ohio Company: Mfg. of thermoplastic elastomers Address: N/A City, State Zip:N/A Contact name: Rodney Shorette, Recruiter Work Phone: 413-746-0101 x202 Fax: 413-746-9101 Email:rod@magellanworks.com Requirements Bachelors Degree 3-5 years plastic or related bulk supplier to auto OEM industry experience. Working knowledge of quality tools such as: Lean Mfg, Six Sigma, Poka-Yoke, 5S, Kaizen, APQP, SPC, FMEA, PPAP, SMED Job Duties Responsible for the day to day quality assurance of the plant. Lead improvement efforts from supply chain through to manufacturing at the direction of the GM. Communicate with customers, suppliers and company staff. Will lead a TS certification effort in the next year. Quality Inspector (added 10/23/2007) Position (Title): Quality Inspector Location: Louisville, Ky Company: Specialty Tool & Machine Address: 3331 Gilmore Industrial Blvd. City, State Zip: Louisville, KY 40213 Contact name: Jon Kuehl,CQM Work Phone: 502-969-8609 Fax: N/A Email: jkuehl@specialtytoolky.com Position Summary We seek a motivated inspector with machining, weld, and fabrication inspection proficiency. An ability to read, understand, and inspect product with geometrical tolerancing features and weld symbols is required. Inspection proficiency includes the ability to operate a CMM for the inspection of highly precision component parts. Requirements If you have at least 3 years quality department experience performing inprocess and final inspection and have working knowledge in the following areas we encourage you apply. Inspection Techniques CMM Operation Calibration Statistical Process Control Technical Mathematics Geometric Tolerancing We offer the following to drive success: An exciting bonus program. Opportunity to advance into team leadership and management roles. Competitive salary and benefits. Quality Engineer (added 10/22/2007) Position (Title): Quality Engineer Location: Jeffersonville, In Company: MedVenture Technology Address: 2301 Centennial Blvd. City, State Zip: Jeffersonville, IN 47130 Contact name: Pam Brown, Human Resource Manager Work Phone: 812-280-6926 Fax:812-280-6927 Email:pabrown@medventure.com Position Summary Quality Engineer with a background in microbiology Duties and Responsibilities Supervisory Responsibilities May oversee other team members in a project matrix on a project required basis. May have a Co-op to supervise and review as a mentor. Major Responsibilities Identify and prepare quality program requirements for product development and manufacturing products. Working understanding of medical design controls and regulatory requirements. Provide support and expertise in the implementation and enforcement of ISO9000, EN46001, MDD, QSR requirements, and any other applicable standards. Develop/review/execute design verification (including biocompatibility, sterilization and package testing) per appropriate ISO/EN/ANSI standards Develop/monitor the effectiveness of the Quality system to identify, bracket, correct, and prevent defects. Provide support and expertise in DOE, reliability strategy, and analytical problem solving techniques. Create/review qualification/validation documents for conformance to business practices. Support ongoing product development and manufacturing. Maintain and develop adequate sampling plans, inspection procedures, and test methods. Access and support suppliers. Performs other related duties as assigned. Requirements Job Experience Minimum of two years related work experience, preferable in a medical device area, or equivalent (except Associate level) Experienced in quality systems (ISO9000 and/or QSR) Education 4 years technical degree, or equivalent experience CQE, CQA (ratings), preferred Experience in Quality Engineering Associate: Degree or 4 years' experience Engineer: 2 - 7 years' experience Senior: 5 - 12 years' experience M.S. degree may account for 2 years experience. P.H. degree may account for 4 years experience. Physical Demands Periodic traveling (e.g. supplier audits, projects support) Quality Engineer & Quality Manager (added 10/05/2007) Position (Title): Quality Engineer & Quality Manager Location: Shelbyville, KY Company: Talis Group, Inc FLSA Status: Direct Hire Contact name: Susan Woods Work Phone / Ext.:  502-581-9896 Fax: 502-751-1105 Email: amccabe@talisgroup.com Overview Direct Hire -Manufacturer of plastics and injection molded products is building a plant on outskirts of Louisville and hiring new Engineers to build their team. They currently need a Quality Engineer and a Quality Manager. Duties and Responsibility Work closely with internal production to ensure quality of product. Introduce and improve systems and technologies in internal production. Help implement quality training. Help set up internal quality standards. Serve customer's needs relating to internally produced products, including such areas as correspondence, quality issues, policy matters and/or any other concerns which may arise during the course of business. Complete appropriate documentation as required. Assist in establishing CPK and Gauge R&R. Make calculations employing mathematical formulas. Maintain a positive influence by behaving in a manner that enhances the success of the department and company. May occasionally be required to travel offsite, sometimes overnight. Ensure that the existing TS16949:2002 quality system is maintained, followed and promoted in the areas of Quality System, Document Control, Process Control, Inspection and Testing, Control on Non-Conforming Product, Corrective and Preventative Action, Training and Statistical Techniques. Qualifications Four Year Industrial Degree. 1-5 years previous experience with Automotive Tier I Manufacturers (Toyota preferred). Injection Molding Experience. ISO & QS Experience. Must be very analytical with a high degree to concentration to interpret blueprints and analytical data. Must be able to communicate effectively with customers, vendors and other associates. Problem-solving and decision-making. Ability to determine probable cause, resolution and correction action plans. Must cooperate effectively, externally and internally, to fulfill essential functions. Must be a licensed driver with a safe driving record Salary for Engineer: $50,000 - $65,000. Salary for Manager: $60,000 - $75,000 Send email in complete confidence to amccabe@talisgroup.com Lean Sigma Black Belt (added 09/26/2007) Position (Title):Lean Sigma Black Belt Location: Louisville, KY Company: Jewish Hospital and St. Mary’s HealthCare Department: Performance Improvement FLSA Status: Full-Time, Exempt Relocation Covered: No Contact name: Michael Waterman Work Phone / Ext. >502-560-8398 Cell Phone / Ext. >502-751-1105 Email: michael.waterman@jhsmh.org Overview Jewish Hospital & St. Mary's HealthCare (JHSMH) is a major regional health network that includes 71 health care facilities with more than 1,900 licensed beds, over 42,000 discharges and over 100,000 emergency room visits annually. JHSMH employs more than 8,100 team members, who are dedicated to providing quality care to the residents of Louisville, KY and the surrounding areas. Primary Responsibility This position is primarily responsible for the expert provision of quality management system, lean, and other process and quality improvement consulting and training services to internal customer throughout the system. Responsibilities also include Internal project identification, prioritization and tracking of improvement metrics. Promotion of multi-site organizational excellence and transformation. Teaches fundamental Lean principles, including TPS tools & philosophy. Teaches and coaches internal clients on Six Sigma and Theory of Constraints principles. Facilitates Value Stream Analyses and Kaizen Events to identify and prioritize improvement opportunities in clinical and office settings. Guides the development, documentation, and implementation of Standard Work. Provides leadership to JHSMH Lean Sigma projects, including the initiation of projects, follow-up, and stimulation of continued project improvements. Qualifications This position requires a Bachelor’s degree in an Engineering or equivalent discipline. MBA, or other post-graduate degree desirable. Minimum 10 years experience in leadership positions in government, academia, or industry. Lean or Six Sigma Black Belt certification (or equivalent). Skills / Competencies Required Demonstrated expertise in leading quality management, lean and/or six sigma projects. Excellent team facilitation and meeting management skills. Demonstrated skill in critical thinking, and relationship building. Highly developed communication skills, successfully demonstrated in effectively working with a wide variety of people in both individual and group settings at all levels of management. Demonstrated problem-solving and inductive reasoning skills which manifest themselves in creative and effective solutions. Ability to organize and manage work to achieve results; track performance so that problems are detected early or prevented entirely. Exhibit a consistent commitment to continuous improvement with ability to inspire individuals and groups to consider new ideas and achieve excellent results. Ability to evaluate the needs of the organization, formulate plans and strategies to meet those needs, and provide leadership to carry out business objectives. Excellent communication, teamwork, and organizational skills. Benefits Medical Insurance, Life Insurance, Dental Insurance, Vision Insurance, Paid Vacation, Paid Sick Days, Paid Holidays, Short Term Disability, Long Term Disability, 403b Plan, Pension/Retirement,Educational Assistance Total Quality Manager (added 09/17/2007) Position (Title): Total Quality Manager Location: Scottsburg, IN Company: Personnel Management Inc. Address: 1499 Windhorst Way, Suite 220 City, State, Zip: Greenwood, IN 46143 Contact name: Bryan Tweed Work Phone / Ext. >317-885-3730 Cell Phone / Ext. >317-266-3317 Fax: 317-885-3755 Email: btweed@workpmi.com Company: Cincinnati, Ohio based corporation is a premier global resource of innovative decorating solutions and packaging services to consumer product and food and beverage companies, national retailers and container manufacturers worldwide. Client is one of the world's largest producers of in-mold labels (IMLs) and heat transfer labels (HTLs), and a major manufacturer of high-quality cut-and-stack and pressure sensitive labels and shrink sleeves. Company has nine manufacturing locations in the United States. Its products are shipped to more than 650 customers in the United States, Canada, Mexico, and Central and South America. Position Description: The Total Quality Manager is a professional who understands quality standards and concepts, can implement organizational assessments, and maintain customer satisfaction and focus. The Quality Manager should manage projects supporting strategic objectives and lead the Quality Department in the support of organizational goals. Basic Accountabilities: Responsibilities include, but are not limited to, the following: Understand statistical evaluation and analysis, to include trend analysis and repeatability and reliability analysis on gages and processes. Ability to resolve quality issues internally and with the customer base. Manage corrective actions plans. Provide input to the management team on the cost of defects and customer claims. Support a customer centered culture in the Plant. Lead team meetings. Build a high performing, skilled team to instill ownership of Plant objectives through selection, performance assessments, training and development of Quality associates. As a member of the safety management team, assure the safety of the associates and the safe use of the equipment. Maintain housekeeping standards. Requirements: Must have Bachelor's degree Demonstrated planning, organizing, problem solving and project management skills Excellent written and verbal communication skills Self-motivating Strong computer skills Prefer high skill level utilizing Lean Manufacturing tools Prefer gravure printing industry experience ISO and AIB experience preferred Travel Requirements: Some travel required. Relocation Provided: Yes. Software Quality Engineering Manager (added 10/12/2007) Position (Title): Software Quality Engineering Manager Location: Boulder, CO Company: Covidien FLSA Status: Direct Hire Contact name: Deborah Cason Work Phone / Ext.:  Not Available Fax: Not Available Email: Deborah.Cason@covidien.com Position Summary Oversee and manage Software Quality Assurance Engineers ensuring that software used in the development, manufacturing, and as part of medical devices is developed according to good design practices as set forth by regulatory authorities (e.g. FDA/TUV).   Minimum Requirements BS degree in Electrical Engineering, Computer Science, or Computer Engineering 6+ years exp in software test or software quality engineering with embedded software as part of a medical device Experience in a management role Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, & Medical Device Directive Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products Working knowledge of C, C++ CSQE Certification Sr. Software Quality Engineer (added 10/12/2007) Position (Title):Sr. Software Quality Engineer Location: 1 position Boulder, CO & 1 position Carlsbad, CA Company: Covidien FLSA Status: Direct Hire Contact name: Deborah Cason Work Phone / Ext.:  Not Available Fax: Not Available Email: Deborah.Cason@covidien.com Position Summary Ensuring that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to division manufacturing plants for computerized system validation.   Minimum Requirements BS in Electrical Engineering, Computer Science, or Computer Engineering 5+ years in software quality engineering role dealing with embedded software that is part of a medical device Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products Understand current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products Working knowledge of C, C++, and LabVIEW Regulatory Affairs Specialist (added 10/12/2007) Position (Title):Regulatory Affairs Specialist Location: Boulder, CO Company: Covidien FLSA Status: Direct Hire Contact name: Deborah Cason Work Phone / Ext.:  Not Available Fax: Not Available Email: Deborah.Cason@covidien.com Position Summary Ensures compliance to FDA and other applicable regulations. Prepares, analyzes, and submits dossiers to various governing agencies in supporting business growths. Supports applicable regulations including ISO, local, state, and/or federal requirements.   Minimum Requirements 5-8 years of RA experience B.S. or B.A. degree required Must have knowledge of U.S. and/or European/International regulations and standards Experience in preparing regulatory submissions Experience interacting with FDA and/or other regulatory agencies Compliance Officer (added 10/12/2007) Position (Title):Compliance Officer Location: Boulder, CO Company: Covidien FLSA Status: Direct Hire Contact name: Deborah Cason Work Phone / Ext.:  Not Available Fax: Not Available Email: Deborah.Cason@covidien.com Position Summary Develops, establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.   Minimum Requirements BS/BA degree or equivalent experience with 3-7 years medical device 2 years auditing experience; hands on experience managing and/or supporting FDA and Notified Body inspection/audits Comprehensive knowledge of FDA Quality System Regulation, ISO, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements Knowledge of all Quality System elements, including Complaint Handling, CAPA, Design Control, Validation Review ASQ Certified Quality Auditor and Lead Auditor training are highly desired For more information about this and other opportunities go to: www.covidien.com/careers. Pull up jobs for Boulder, CO. Respiratory jobs are listed under Nellcor/Puritan/Bennett.