The Supply Chain Quality Engineer is responsible for liaising with operations to ensure supplier controls are met. They must ensure that quality standards are met in accordance with regulatory requirements and company policies for all Dynex products and systems.
Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) supplier approval, supplier evaluation, non-conforming product and improvement projects in operations:
- To perform risk analysis
- To perform audits and prepare audit reports
- To oversee non-conforming material process
- To produce trend data and metrics
- To improve key quality metrics in support of all areas of responsibility
- To perform discrete quality improvement projects
- To maintain supplier control files
- To approve suppliers for use
- To oversee supplier corrective actions
- To re-evaluate the supplies for continued use
Ability to communicate effectively with all levels of technical and professional personnel. Excellent problem solving skills. Adaptable to change and multi-tasking. A hands on approach that encourages improvement.
Minimum Qualifications / Education:
B.S. Degree in Engineering or any science related field preferred, 3 years related experience in regulated industry in lieu of degree will be considered. Broad knowledge 21 CFR 820, ISO 13485, ISO 14971. The ideal candidate will also possess a lead auditor qualification.
Basic Microsoft Office suite skills, MS Project.
Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.
DYNEX Technologies, Inc. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. DYNEX Technologies provides medical, dental, life and disability insurance, Section 125, 401(k), flexible schedules, educational assistance and a great work environment!