1. Develops and executes engineering and technology transfer protocols to ensure conformity of purchased material and manufactured products to specified customer and company standards.
2. Uses Lean Six Sigma methodologies to conduct root-cause analysis of and implement solutions to prevenance and utilization in the execution of manufacturing activities.
4. Uses statistical tools to produce department and organizational performance dashboards that support data-driven decision making.
5. Implements and continuously improves inspection and testing methods for receiving in-process and finished goods.
6. Production team support - acts as first-line support to Blenders for queries on batching issues, chemical interactions, ingredient/supplier substitutions, etc. plus supporting with ongoing training of the Blending team
7. Manufacturing R&D support: engages with R&D and product management in supporting the development and optimization of new and existing products with a view to ensuring high quality and efficient internal production
8. Manages evaluations of existing and prototype products against known regulatory, industry, customer, and company standards.
9. Analyzes quality trends to identify opportunities for improvement, need for corrective action, and to anticipate potential delays or defects.
10. Provides analytics to support supplier management and supplier qualification programs.
11. Resolves quality issues collaboratively with colleagues, suppliers, and customers.
12. Develops, maintains, and implements quality management system documentation to meet or exceed ISO13485 and 21CFR requirements.
13. Maintains accurate and user-friendly materials safety data sheets (SDS), product labeling, and facility labeling in collaboration with marketing, technical products, and quality colleagues.
14. Performs in a manner consistent with company Core Values and Purpose.
15. Exercises discretion and independent judgment on significant matters.
16. Attends all scheduled meetings, missing no more than 10% annually.
17. Provides excellent customer service.
18. Follows all OSHA and other safety guidelines.
19. Actively demonstrates teamwork at all times.
20. Adheres to company safety standards at all times, such that no serious (requiring medical attention) injury occurred during the prior 12-month period.
21. Follows other policies and procedures such that there are no verbal or written warnings during the evaluation period.
The duties described above are not inclusive. Additional duties may be permanently assigned or required from time to time due to the need to respond to customer needs and remain competitive in the marketplace.
Work environment characteristics described here are representative of those that must be met by a Team Member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Bachelor's Degree in life sciences, chemistry preferred or related field with equivalent experience.
2. Familiarity operating within the parameters of a quality management system designed for an ISO13485 facility and/or other related medical device manufacturing experience.
3. Experience with method validation and technology transfer/process development activities to ensure seamless introduction of processes into manufacturing.
4. Experience with Lean and Six Sigma methodologies.
5. Experience in writing technical documentation, procedures, and work instructions.
6. Ability to examine documents for accuracy and completeness.
7. Fluently speak, read, and write English. Ability to speak, ready, and write Spanish a plus.
8. Effective written communication skills.
9. Ability to perform the following mathematical functions:
a. add, subtract, multiply, and divide in all units of measure, using whole numbers, fractions, and decimals.
b. compute rate, ratio, and percent.
c. compute mean, median, mode, max, min, range, and standard deviation.
10. Ability to create, interpret, and explain quality management tools.
11. Ability to create, interpret, and explain the following statistical tools and their outputs:
a. calculate sample size, confidence intervals, process capability.
b. control charts and associated statistics.
12. Able to effectively use the following software programs as an intermediate user:
a. Microsoft Office Suite
13. Demonstrated ability to effectively speak in front of groups of co-workers and vendors.
14. Demonstrated ability to be self-motivated and work with minimal supervision.
15. Skilled in time management and managing multiple simultaneous tasks.
16. Ability to apply common sense understanding to carry out instructions furnished in written, oral, and diagram form. Ability to deal with problems involving concrete variables in standardized situations.
17. Demonstrated customer problem solving skills.
18. Ability to meet physical demands of the job which include, but are not limited to: walking; bending; pushing; pulling; sitting for extended periods of time at a desk using a computer, phone and headset; and occasionally lifting and carrying items which may weigh up to 50 pounds.
19. Position spends approximately 50% of time sitting at a desk and 50% standing or walking - lab responsibilities.
20. Vision and hearing must be within or correctable to within normal range.
21. Must work from the corporate office and be able to work on time on a regular basis during regular business hours.
22. While performing the duties of this job, the team member is exposed to computers and general office equipment approximately 50% of the time. The noise level in that work environment is usually quiet. The other 50% of the time will be working in the production facility where the noise level is high.
This position is onsite, mostly in our McKinney location. Occasional travel to our Arlington facility. This position pays between $95k- 105k annually with a potential of 7.5% bonus annually.
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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