ARE YOU A FIT FOR THIS POSITION? SEE BELOW!
Under the direction of the Director of Quality, responsible for the coordination of the activities required to meet quality requirements/standards. The Senior Quality Engineer interacts with other managers and staff throughout to ensure that the Quality System is functioning properly and provides training, tools, and techniques to enable others to achieve product quality and meet customer and Quality System requirements. This includes supporting Quality Management System processes such as CAPA, Complaints, Internal Audits, Customer Audits, Nonconformances, Training, Document Management, and Supplier Quality.
- Must be able to plan, organize, and implement multiple concurrent tasks and projects.
- Must be able to interpret complex engineering drawings and specifications, and have a good understanding of ASTM standard requirements.
- Develop, implement, and maintain quality systems, policies, and procedures that ensure compliance of the organization to ISO 13485, and GMP / FDA regulations (as applicable).
- Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. inspection procedures, and equipment manuals).
- Must be able to analyze and correct complex product and/or process issues using independent judgment.
Bachelor's technical degree (Plastics Engineering, Chemical Engineering, Quality Engineering, Materials Science, Chemistry, or the like).
- Good computer skills (word processing, spreadsheets, Minitab).
- Excellent analytical skills and promotes a problem-solving work style.
- Excellent interpersonal communications skills.
- Demonstrated ability to operate small hand tools, and inspection equipment.
- Demonstrated knowledge of cGMP and other regulatory requirements as they apply Medical Device manufacturing and validation is desired.
- Must be willing to travel (approximately 5%).
Education and/or Experience:
- Bachelor’s degree in a scientific field or previous Quality Engineer experience with an engineering certification (i.e. CQE). 5-8 years of relevant experience preferred.
- Must be able to interpret ASTM standard requirements. Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Certificates, Licenses, Registrations: ASQ CQE, and CQA. Other quality certifications are a plus.