The role of the Sr. QA Engineer I is to work with the Quality Ops team and mentor the QEs (Quality Engineer) and QE technicians to ensure quality standards, deviations, investigations, and process enhancements are completed. A quality engineer works within a wider team of quality professionals with the overall aim of maintaining the quality of the final product. This includes collaboration with MS&T, manufacturing, and other quality personnel for evaluating, investigating and establishing enhancements to reduce and prevent future quality impact. Risk assessment functions and statistical control evaluations for current product processing and deviations covering final product release, sterilization, packaging and labeling, delivery system manufacturing and critical utility and environmental.
• Provide mentoring through reviews and feedback to the QEs and QE technicians to ensure compliance, proper deviation impact to product assessments and enhancements. • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. • Collaborates with MS&T and manufacturing functions to ensure quality standards are in place. 5. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications. • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. • May specialize in the areas of design, incoming material, delivery systems, sterilization and final product processing for production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Key Performance Indicators:
Complete understanding and wide application of technical principle, theories, and concepts in the field. General knowledge of other related disciplines. Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives. Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources. Frequent inter-organizational and some customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects and enhancements.
- Company Name
- Huntington, WV
Bachelor Degree or equivalent number of years of relevant experience. Preferred: Bachelor Degree in Science. Excellent knowledge of written and verbal English. Two (2) years of applicable experience. Preferred: experience in validation, quality engineering, root-cause analysis, and supervision in pharmaceutical, medical device or related industry.
- How to Apply