PSI/EYE-KO, Inc. is a manufacturer of ophthalmic medical devices is looking for a Director of Quality Assurance.  This is a full time salaried position.

We require experience and familiarity with:  ISO 13845; CE registration; CAPA; and GMP.

You will be responsible for compliance with ISO 13485, CE registration, CAPA, and FDA regulations and coordination with all regulatory authorities including FDA, Health Canada, and the EU.

Daily activities include the above and responsibility for maintenance of technical files and regulatory records; SOP’s and SOP training; and internal audits.

This is a hands on position responsible for all aspects of quality assurance and quality control working with the Plant Manager, 25 employees, and reporting to the President of the Company.

We are a small closely held company, in business for over 25 years, located in our own facility in O’Fallon, Missouri, a suburb of St. Louis.  For more information visit our web site at www.eye-ko.com.

Please forward your resume, salary history and requirements to employment@eye-ko.com.

Reports to: Directly - Director of Information Technology
Indirectly - Vice President of Technical Services
General Category: Full-time employee for Food Industry position
Working Environment:

• Office Work - Typical office in a controlled environment.

• Plant Floor - Exposure to cold temperatures, wet and/or humid conditions, moderate noise levels, and to other general physical hazards of working on or around machinery in a food processing facility.

 The candidate selected by WLF initially will establish and direct a Statistical Process Control Program requiring selection of a COTS SPC software package followed by the design, implementation, training, coordinating and effective maintenance of this program in a continuous improvement environment.

Later growth opportunities will result after accomplishment of the SPC program success and continuous improvement of the QA applications.

A. WLF “Must Haves” for this position
1. Five or more years experience in a food industry or similar operation.
2. BS or BA degree from educational program having a curriculum with strong quantitative emphasis.
3. Certification by a recognized professional organization (e.g., ASQ’s certification program for engineers [CQE], six sigma black belts [CSSBB] or software quality engineers [CSQE]).
4. Quality Assurance expertise with strength in Information Technology applications, especially COTS SPC software; and knowledge of database software, Internet software, Project Management software, spreadsheet software and word processing software.
5. Experience in implementing a statistical QA program from planning, software selection, designing, training, implementation and maintenance in a continuous improvement environment; including communicating effectively orally, in writing reports, in business correspondence, with procedures, and in training manuals; with an emphasis on describing complex systems in non-technical terms.
6. Able to effectively present information and respond to questions from groups of managers, vendors and customers.
7. Experience in analyzing data produced from QA activities resulting in management-level reports and presentations with recommendations for improvement; scheduling and tracking ideas selected by management; and reporting on actions taken and results.
8. Expertise in leading a team-based problem solving program for plant-level employees including focus on team functioning and problem-solving tools, also including basic math, algebraic computations, statistics, regression analysis, and statistical process control methodologies.
9. Capability in providing plant-level displays and reports of quality achievement, showing departments “how well they are doing.”
10. Proven leadership of organization-wide, quality improvement applications including interface with top management and all other levels including hands-on employees; customers; and vendors.

B. Other Qualification “Strong Points” - for review to enhance the applicant’s potential offering to WLF
1. Candidates possessing in-depth working and administrative knowledge of one of the following Statistical Process Control software packages (other than Excel) will be given preference.

• Hertzler (GainSeeker)
• Zontec (Synergy)
• InfinityQS (Proficient w/DAS, eSPC)
• DataNet (WinSPC, QualTrend)
• Northwest Analytical (Quality Analyst/Monitor, NWA SPCx/QAx)

 2. Possess an in-depth understanding of Hazard Analysis and Critical Control Point (HACCP) requirements for the food industry.
3. Have a basic understanding of budgeting and the budgeting process at the company level, with strong business acumen.
4. Be able to formulate and maintain quality program objectives complementary to corporate policies and goals.
5. Know the basics of Lean Six Sigma and is able to bring these concepts to the training of problem-solving teams
6. Know how to apply the analysis of variance techniques for improvement applications.
7. Have experience with flow charting processes including Value Stream Mapping and Analysis.
8. Participate with customer complaint activities in support of customer satisfaction.
9. Formulate and recommend WLF policies, strategies, tactics and goals related to quality.

If you are interested and meet the above criteria, please contact:

Ms. Jaime Parizek, HR
Jaime.Parizek@wlfoods.com

Weir Minerals Lewis Pumps is a medium sized manufacturing company of approximately 100 employees located in Crestwood, MO, that has been in the business of supplying pumps and valves to the worldwide fertilizer market for more than 100 years.

We are currently seeking a SENIOR QUALITY TECHNICIAN to report to the Quality Assurance Manager.

Essential Job Functions

• Utilize continuous improvement principles and techniques to assure product quality.
• Prepare customer reports, data analysis and customer required documentation.
• Support and maintain Quality Planning.
• Perform Quality Management systems and Special Process audits including reporting follow-up and closure of audit reports and non-conformances.
• Utilize FMEA, PPAP, poke-yoke, six sigma, SPC and other related tools to drive quality improvements.
• Maintain all procedures and work instructions as it relates to manufacturing operations and plant quality. Maintain quality standards and protocol for assembling and/or finished product.
• Work with customers and/or supplier partners on non-conformance reports and customer/supplier corrective action plans.
• Conduct customer and/or supplier visits as required.
• Conduct root cause analysis and corrective action plans (CAPA).
• Act as a member of the MRB team - responsible for disposition of non-conforming material.
• Conduct & review First Articles, Product ID & Traceability, Visual Aides and Quality Plans for all products for both internal & external suppliers.
• Manage all aspects of Metrology to include document control, calibration records, procedures & audits, gage calibrations and certifications, as well as layout measurements prior to gage acquisition. Document all gage calibration, inspection and repair services.
• Develop procedures and work instructions for gauging and inspection operations including GR&R studies.
• Assist/support inspection and measurement for 1^st piece set-up for manufacturing operations.
• Perform polish /acid etch, UT (metal), dye penetration and microstructure analysis testing.
• Provide training on topics such as Blueprint reading, Metrology, Geometric Dimensioning & Tolerancing.
• Monitor and Maintain Vendor Management Inventory (VMI).
• Support Engineering Change Order, Manufacturing and Production.
• Interpret Drawings, Non-conformances, Design changes for production & customer impacts.

POSITION QUALIFICATION REQUIREMENTS

Education: Requires a minimum of a 2 year college degree in a technical discipline.

Experience: Requires a minimum of five years or relevant Quality Assurance experience to gain sufficient knowledge to perform the requirements of the position.

Skills and Abilities which may be representative but not all inclusive of those commonly associated with this position:

• Ability to effectively communicate and present information to team members, management, suppliers, and customers.
• Knowledge in the use of continuous improvement principles and techniques as applied to manufacturing functions.
• Good Leadership & Facilitation Skills
• Ability to communicate key product characteristics, then apply quality assurance methodology to control key process parameters (PPAP, Six Sigma, SPC, gage R&R, FMEA, and Poke -Yoke…)
• Knowledge of ISO 9001/14001

Machines, Tools, Equipment and Work Aids: Computer, MSWord, MSExcel, MSPower Point, MSProject, Acess, Visio, Mintab, SPC-XL

Please submit resume to apply@lewispumps.com

 Global Quality Management System Lead

The Global Quality Management System Lead is responsible for providing global Seed Supply quality management (ISO 9001:2008), serving as the Seed Manufacturing liaison for North American Regulatory/Compliance activities, along with global Seed manufacturing leadership for Stewardship and Biotechnology Initiatives. This is a unique opportunity to develop quality standards on a global basis by developing quality management biological systems.

Monsanto is an agricultural company. We apply innovation and technology to help farmers around the world produce more while conserving more. We help farmers grow yield sustainably so they can be successful, produce healthier foods, better animal feeds and more fiber, while also reducing agriculture’s impact on our environment.

Responsibilities include:

Overseeing implementation and maintenance of the Quality Management System (QMS) at all global seed production operations, quality labs, and production research programs

Responsible for ensuring that the QMS is compliant to the standard and for capturing maximum business value through system maintenance, monitoring, and improvement.

Work closely with the various Seed Supply Management groups in ensuring processes, procedures, and systems are in place to ensure quality management effectiveness, operational consistency, and identification of process improvement opportunities.

ISO certification for Seed Supply through system auditing, maintaining relationships with external registrars and quality networks, analyzing system effectiveness regionally, and ensuring clear management support and direction for the sites.

Manages the corporate QMS by participation in row crop and vegetable seed management reviews, and support as needed for documentation management, managing corrective and preventative actions, and implementation of continuous improvement opportunities.

Audit sites globally to ensure ongoing compliance and implementation of best practices across all facilities. 

Required Skills/Experience:

MBA or similar degree

Minimum 3 years experience in managing ISO9001 standards or other quality management systems

Minimum of 7 years operational or process experience (i.e. manufacturing process, QMS, supply chain, logistics)

Organizational leadership experience spanning across multiple sites

Excellent communication (written and oral), interpersonal, organizational and negotiation skills

Demonstrable experience leveraging external and internal relationships and networks

Strong results orientation or self motivation.

Desired:

• Six Sigma Black Belt certification
• Undergraduate in agronomy, sciences, engineering, similar
• Previous work experience in a global environment
• Significant Project Mgt experience
• Experience with cross-functional and diverse workgroups
• Ag industry experience
• Active in National and Local ASQ

If interested, please click here and apply to requisition #0012B