Job Opportunities

Location: Northern Illinois.
Company: $2.4B food manufacturer that currently has 19 plants.

Experience:

Experience working with any types of food/beverage products would be considered. Must have a B.S./B.A. Degree. Must have food/beverage industry experience.

Brief Position Summary:

• The position is open due to replacement
• Reports to the Quality Assurance Manager
• Primarily a day shift position hours are as needed/required
• Reports include 12 hourly lab techs (represented by Teamsters union)
• Responsible for all aspects of quality during the production shift
• Work closely with and communicate to operations, ensuring all finished products meet specifications and customer expectations, while the facility reaches optimum quality, efficiency and world-class food safety.
• This plant has about 95 employees (10 in the Q.A. lab)
• This plant runs (2) shifts of production and full sanitation every night
• The company offers a competitive base salary, strong benefits and relocation assistance.

If you would be interested in learning more about this opportunity please contact:
Email: Phil Kulwicki, pmk@wi.rr.com
Kulwicki Group
Phil Kulwicki, President
Waterford, WI 53185
262-534-3335

To learn more see LinkedIn: Phil Kulwicki Recruiting for the Food & Beverage Industry

Requirements: The Black Belts or Master Black Belts must:

• Demonstrate a strong executive presence,
• Change agent & change management skills,
• Demonstrate emphasis and strong experience in the leading and facilitation of Value Stream Mapping, Kaizen events and utilization of Lean tools.
• Develop Lean Six Sigma strategies and provide guidance, coaching, and mentoring of executives and/or project teams with DMAIC LSS projects, ZIP-Forward events and Kaizen activities.
• Must train green belts.
• Must have experience with organizing black belt and green belt training.
• Must be able to lead enterprise level projects, including areas such as plant operations, delivery operations, logistics and maintenance.

Other Requirements:

• Subcontractor must pass a background check to gain access to facilities and must be U.S. citizens.
• Candidates must be eligible to work in the US without sponsorship

Compensation:

• The contract rate is up to $75/hour (1099) or W-2 salary of $90-100k with benefits (e.g., vacation).
• This position is responsible for onsite work, Monday – Friday, not including most federal holidays. Relocation and travel to/from home are not available for this position.

To Apply and more information:

Send email to Lois Douglas resumes@theleadingniche.com with job: DR0313-009 in title.

National Telecommunications & Information Administration, United States Department of Commerce.

DIRECT HIRE announcement: NTIA-ITS-2013-0010.

• Institute for Telecommunication (ITS) has been given Direct Hire authority to fill this particular job because good IT Security Officers are very difficult to recruit.
• With this authority, ITS can select anyone who is qualified and meets specialized experience, i.e., IT degree and Security Officer certifications.
• There is only 1 question asked in the application process,
• Focus efforts mainly on preparing a well written resume.
• This is a high stress position.
• It requires someone who has strong technical, leadership, and interpersonal skills.
• The person should also have a high tolerance for bureaucracy and procedures.
• Person will be interacting daily with the IT operation in Washington, DC.
• This position will be filled at a band IV because of the high performance and qualification requirements.

For more information contact:
Email: Pete Baston, pete@ideapete.com
Phone: 303-578-0886
To apply visit: USA Jobs

Bonfils Blood Center.
Department: Quality Assurance and Regulatory Affairs.
Requisition Number: JC10222.

Position Summary:

• Responsible for the effective implementation of Bonfils’ quality assurance processes related to collection, processing, testing, storage and distribution of blood and blood components.
• This includes equipment/ systems specification development, validation of equipment/systems, supplier quality management, process development, technical support related to quality problems, corrective action and continuous improvement change management, process control, statistical techniques, and non-conforming material and product disposition.

Minimum Education Required:

• Bachelor’s degree from an accredited college or university in Chemical, Mechanical, Electrical, Biomedical, and/or Industrial Engineering.

Preferred Experience:

• 5-10 years in validation of Equipment/Systems
• 5-10 years experience in quality engineering and process development
• 5-10 years experience in an FDA regulated environment such as Medical Device, Pharmaceutical, or Biologics
• 2-5 years experience in Continuous/Process Improvement, DMAIC/LSS, etc

Knowledge of the following quality systems:

• Process/Equipment validation
• Corrective Action and Continuous Improvement (CACI) also known as CAPA
• Non-conforming material and product management
• Process/Product development
• Statistical techniques via understanding of Statistical Process Control (SPC)
• Strong technical/engineering skills
• Strong written communication skills including writing, editing, and proof reading
• Strong interpersonal skills
• Computer skills
• Excellent oral communication skills
• Ability to handle multiple projects
• Ability to manage technical people and information

Review this and current employment opportunities:
Category: Quality/Compliance
Location: Colorado
Requisition Number: JC10222
For more information Contact: Julie Carroll, Employee_Recruitment@Bonfils.org

A Pharmaceutical Manufacturer is looking for Quality Engineer for long term contract position in PA.

• Candidates should have a minimum of 5 years experience working in a GMP pharmaceutical or medical device environment
• ASQ certification, Six Sigma experience, statistical analyses and or knowledge of Process Excellence tools is desirable
• Knowledge and experience with ANSI is desired
• Must have strong oral and written communication skills
• Candidate will create sampling plans and AQL inspection criteria
• Evaluate and revise documents, procedures, sampling plans and inspection criteria based on the harmonized requirements as defined within approved standards and SOP’s
• Develop training modules and provide training for the revised sampling plan and AQL requirements, as needed

To learn more see LinkedIn: Toni Maksym, Recruiter, Heathcare & Scientific, Philadelphia, PA

Position no longer available

Air Squared is searching for a local experienced Quality (external Lead Auditor) person to perform our ISO 9001 Internal Audit (temporary/contract).

Air Squared is in our Re-certification year and would like “fresh eyes” to audit our QMS.

Air Squared have worked with several ISO “consultants”.

Now Air Squared would like to develop a relationship with a local auditor, perhaps a retired person looking for limited part time work, or special project.

To learn more contact via email: Carl McKinley, c.mckinley@airsquared.com
Or Phone: 303-466-2669

Job Description

• The Continuous Improvement (CI) team was created in 2009 and its main goal is to lead development of continuous improvement expertise in district staff and support implementation of district-wide projects. Currently we support 12 academic and operations departments with 100 active employees in training and implementing projects.
• The CI team utilizes Continuous Improvement methodologies to reduce administrative and operational costs, and improve services to schools, parents and students. Most of our efforts are Lean projects with few Lean Six Sigma and Six Sigma projects. The CI team had the opportunity to lean out historical costs, streamline operations and provide better services. The Continuous Improvement Team is 100% aligned with The Denver Plan resulting in better overall customer satisfaction for DPS’ students, parents, faculty and employees. Our approach is to mentor employees in three levels of Continuous improvement training, including lean practitioners, green and black Lean Six Sigma belts. The CI team increases awareness about benefits to DPS and to individuals, supports project definition, and shares best practices with other Performance Management initiatives within the district.
• The current departments that are working with the Continuous Improvement team includes: Academic Elementary, Secondary, Office of the Chief Academic Officer, Academics Early Education, Academics Extended Learning, Financial Services (Budget, Purchasing, Grant Management, Federal Programs, Student Submissions, Student Data Quality Management, Account Payables, Payroll), Office of Choice and Enrollment Services, Human Resources, Department of Technology, Transportation, Enterprise Management (Food and Nutrition Services, Warehouse and Distribution, Fixed Assets and Mail Delivery), Facilities (Construction Services, Grounds, Maintenance, Operations), and Planning and Analysis.

To learn more see LinkedIn: Guillermo (Gil) Echeverria, Continuous Improvement, Denver Public Schools

Job ID# 2013001069
Covidien Location: Boulder, CO

Covidien has an exciting opportunity for:

• Medical Affairs Project Manager in Boulder, CO
• This role will act as clinical project lead, managing all aspects of multiple clinical research projects by planning, developing, and writing clinical protocols; creating and updating study documents;
• Recruiting and training investigators; organizing and participating in investigator and FDA meetings;
• Interfacing with investigators, site coordinators, field clinical personnel, and sales representatives;
• Analyze clinical progress reports for scientific and technical accuracy;
• Prepare clinical reports.

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.

Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies.

With 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries.

Whatever your specialty or ambitions, you can make a difference at Covidien – both in the lives of others and your career.

To learn more visit: Covidien Job 2013001069: Medical Affairs PM
Also see LinkedIn: Keri Mazza, Sr. Corporate Recruiter, Covidien

Job ID# 2012007605
Location: Boulder, CO

SUMMARY OF POSITION:

• Covidien is driven to improve people’s lives through healthcare innovation and are looking for a driven and independent engineer that shares our passion for quality. In this position you will be part of a cross functional team that partners with internal manufacturing and OEM partners located globally. Covidien wants someone who is self-driven and ready to learn new technologies.

ESSENTIAL FUNCTIONS:

• Develops, modifies, applies and maintains quality evaluation and control systems and protocols.
• Collaborates with internal supplier/customers to ensure quality standard are in place.
• Audits quality systems for deficiency identification and correction.
• Ensures that corrective measures meet acceptable standards and that documentation is compliant with requirements.
• Investigates deviations and out-of-specification results.
• Work with Contract Manufacturing suppliers to resolve quality issues and evaluate change requests.
• Evaluates potential design, material and process changes for adequate justification and testing.
• Represents the QA function on product transfers.

MINIMUM REQUIREMENTS

EDUCATION:

• BS in Engineering, Physics, Mathematics, Science, or technical field with emphasis on statistical skills.
• Advanced degree preferred.

EXPERIENCE:

• 2+ years of experience in Operations Quality Assurance or related field.
• Demonstrated leadership and communication skills.

PREFERRED SKILLS/QUALIFICATION:

• FDA/ ISO/ GMP knowledge base
• Experience in a high volume production facility in the medical device industry
• Operational Excellence/Six Sigma/Lean training or certifications
• Knowledge of various sampling plans
• Knowledge of various Quality systems

To learn more, visit Covidien Job 2012007605: Operations Quality Engineer

Job ID# 2013000081 and 2013000760
Covidien Location: Boulder, CO

SUMMARY OF POSITION:

• Works together with the R&D, Procurement, New Product Introduction and Engineering organizations related to the family of products under his/her responsibility in order to lead the Supplier Management process from product development to product sustaining activities. Works as the liaison between Covidien Surgical Solutions Division and Manufacturing to ensure the supplier management process results in the highest level of quality products.
• Candidate must have an engineering background including experience in production environment in the medical device field. Strong analytical, written and verbal communication skills are a must. Some travel is required. Applicant must demonstrate the ability to deliver innovative, cost-effective and timely solutions in a multiple project environment.
• Oversees all aspects of supplier quality management from the product families under his/her responsibility by:
• Certifying suppliers based on risk assessments and in accordance with current ISO/GMP/MDD requirements.
• Conducting surveillance audits; complete reports and follow up on any related activities including updating supplier corrective action database, following up and closing corrective actions
• Maintaining supplier audit schedule, and assisting in the maintenance of the supplier files
• Creating and monitoring supplier performance metrics in alignment with business objectives and report on performance to suppliers and management.
• Participating in product development teams to develop plans for new suppliers under the new product Introduction PDP process or the OEM Supplier General Development Plan.
• Leads the certification of new suppliers related to new products by performing risk assessment and initial audit.
• Responsible of transferring new suppliers to GBU facilities no later than the design transfer review or as applicable according to the different supplier quality controls per facility.
• Is the GBU representative for supplier quality corporate initiatives and participates by bringing voice of the customer into the definition of corporate systems and/ or processes.
• Assessing changes that may impact supplied product and services by supporting applicable sustaining development initiatives.

MINIMUM REQUIREMENTS

EDUCATION:

• Bachelor’s Degree in Engineering, Science or technical field.

EXPERIENCE:

• Five (5) years experience in Supplier Quality Engineering; with experience in the Drug/Medical Device industry.

SKILLS/QUALIFICATIONS:

• Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM-Certified Quality Manager, etc.).
• ISO 13485 Lead Auditor Certification
• Experience with measurement system analysis (MSA)
• Quality System Regulation 21 CFR Part 820 training
• 21 CFR Part 11 training
• ISO 17025 training and auditing experience

To learn more, visit Covidien Job 2013000081: Sr Quality Supplier Specialist
Or, visit Covidien Job 2013000760: Sr Quality Supplier Specialist