Description
The Quality Assurance Engineer 3 is responsible for providing Quality Assurance input and guidance for Manufacturing, Supply Chain Quality, and R&D activities. Responsible for supporting quality assurance and regulatory issues to assure compliance with FDA regulations, corporate directives, ISO 13485 standards and Company strategies.ESSENTIAL JOB FUNCTIONS
1. Support of Quality initiatives and acitivities to enusre a successful Defiance season.
2. Support the CAPA system by working towards streamlining the process and ensuring compliance to FDA and ISO standards. Also investigate and process CAPA's that require Quality Assurance involvement.
3. Perform investigations and implement Corrective Actions for Complaints where injuries are involved. Also elevate Complaint investigations where break-downs in the process are evident and initiate Corrective Actions to address those issues. EDUCATION/EXPERIENCE:
- A bachelor's degree in a related field and/or a combination of practical and educational experience in the medical device industry.
- Three plus years of experience in engineering with an emphasis in one or more of the following required: Design Control, Supplier Quality and/or processing of Non-Conforming Material.
- ASQC certification with active local membership is preferred.
- Experience with the application and implementation of (GMP/QSR/ISO/MDD and Canadian Medical Device) regulations a plus.
- Experience with Quality (QFD, SPC, Risk Analysis, DOE, TQM, etc.) and LEAN (Kaizen events, 5S+1, value stream mapping, etc.) related tools also a plus.
To find out more about Real please visit www.realstaffing.com