Shaklee Corporation is a multi-level marketing company that has been around since the 50’s. They manufacture and sell dietary supplements. Much of their manufacturing is done by contract manufacturers.
Shaklee is looking for engineers—chemical, mechanical, or manufacturing—to train as process-oriented quality engineers. The Shaklee Quality Engineer position involves multiple facets, including:
1. Conventional quality engineering focused on definition and observation of quality attributes to determine conformance to specifications;
2. Process analysis and development to solve quality problems upstream;
3. Knowledge and application of the current federal regulations (GMPs) as applied to dietary supplement manufacturing.
Because Shaklee employs multiple contract manufacturers to produce their products, the job will involve a significant amount of travel. The home location is Pleasanton, California. Housing costs in the Pleasanton area and west toward San Francisco are on the high side. But there are several areas to the east within a reasonable commute that have excellent home values.
Job Description
Title: Quality Engineer and Senior Quality Engineer
Job Summary:
To ensure that all products and materials are manufactured according to applicable specifications and cGMPs;
and to ensure that they meet all quality requirements and applicable regulatory requirements.
Job Functions:
1) Implement and analyze current quality monitoring methods, systems, and tools and develop and
implement new ones to increase effectiveness and efficiency.
2) Collect, report, and analyze quality data to understand trends, to identify potential problems, to identify
quality improvement actions and initiatives, and to determine the effectiveness of quality improvement
initiatives.
3) Write and train others to write validation protocols and reports and to conduct validation experiments.
4) Understand manufacturing processes and equipment; apply process-engineering quality management
methods; implement new process-engineering quality management methods.
5) Work with third-party manufacturers and corporate manufacturing operations (hereinafter, “Suppliers”) to:
a) Ensure compliance with cGMP and corporate requirements according to applicable cGMP
requirements and established corporate procedures.
b) Conduct and document compliance audits.
c) Conduct training and monitoring visits to teach the corporate Quality Management System.
d) Provide assistance to evaluate and validate new production and packaging equipment.
e) Provide training in the necessary procedures for holding, manufacturing, warehousing and distribution
of products, raw materials and packaging components.
6) Conduct and properly document pre-production audits of potential third-party manufacturers.
7) Support raw ingredient procurement and supplier management to certify raw material and packaging
suppliers.
8) Support corporate specifications owners to define quality attributes and acceptance and rejection criteria
for products and materials; and to ensure that quality requirements are effectively addressed in all
corporate material specifications.
9) Assist in the evaluation of new types of packaging to improve product quality.
10) Write and assist others to write guidelines and SOPs to communicate corporate quality management and
monitoring procedures to Suppliers.
Additional Job Functions, Senior Quality Engineer:
1) Work independently to develop and manage projects of increased scope.
2) Propose new ideas and methods to improve effectiveness and efficiency of quality systems
3) Mentor other quality engineers in Nu Skin and industry best practices in quality management.
Qualifications:
1) BS degree in engineering or equivalent experience in production and quality management.
2) Minimum of 5 years work experience, at least 2 years directly involved with specifications, standard
operating procedures, and product quality.
3) Ability to work cooperatively with product development, supply chain, marketing, and suppliers.
4) Experienced level computer skills including word processors, spreadsheets, databases, quality
management software, and statistical analysis applications.
Additional Qualifications, Senior Quality Engineer:
1) 8-10 years of work experience in engineering or equivalent experience in production and quality
management.
2) Knowledge, experience, and skills to mentor other quality engineers and Supplier quality personnel.
3) Big-picture knowledge and creativity to develop new quality management concepts, methods, and systems.
Definitions:
1) cGMP: Client seeking quality engineers is engaged in the development, production, and marketing
of dietary supplements and personal care products that are regulated by the US FDA. The applicable
regulations are referred to as Current Good Manufacturing Practices (cGMP’s).