The role of the Sr. Quality Engineer II, reporting to the Quality Engineering Manager is to be the single point of contact for all new product transfers to the Huntington and the site change control program.
1. Provides Quality support to all new product and technology transfers to the AODC facilities.
2. Collaborates with R&D New Product Transfer team to ensure quality standards are in place in transfer documents and manufacturing processes steps.
3. Drives the qualification of new suppliers related to new product and tech transfer projects.
4. Ensures all technology transfer and new product projects are successfully executed, fully documented and compliant with all corporate and regulatory requirements. 5. 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.
6. Manages site change control program to ensure compliance to corporate and regulatory requirements. Role models best practices, leads and influences others to deliver best in class change control process without direct authority.
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. Assure the site change control program is in compliance with the regulatory and corporate requirements.
- Company Name
- Huntington, WV
Bachelor’s Degree or adequate experience.
Minimum 5 years of applicable professional experience.
Excellent written and verbal English.
Bachelor’s degree in a scientific discipline or engineering.
Experience in validation, quality engineering and supervisory level in pharmaceutical, medical device or related industry.
ASQ certified QE recommended.
- How to Apply