Description
The Quality Engineer will:- Write and coordinate efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR compliance.
- Develop and leads multiple activities and large complex projects (e.g. Process Validation, CAPA Projects)
- Document Change Order support. Provide QA signature to design and process changes. Ensure process is implemented properly and QA issues have been addressed.
- Support or Lead Material Review Board. Facilitate MRB activities as assigned by QA management.
- Facilitate the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality perspective.
- Facilitate the execution of Design FMEA and Hazard Analysis and other applicable risk analysis.
- Support Calibration and Preventive Maintenance activities.
- Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
- Ensure that all projects are in compliance with GLP, QSR), ISO or other applicable requirements.
- Participate in FDA inspections, ISO Certification and Surveillance audits and customer audits.
- Audit internal groups or programs and external vendors for compliance with corporate and international regulatory guidelines.
- Interact and coordinate activities with other departments, external vendors and customers.
- Assist or lead in the prompt implementation of Non-Conformance resolution, Complaint Investigation and Corrective & Preventative Action(s) (CAPA) support.
- Ensure that all projects, including appropriate documentation such as: protocols, technical reports, validation/quality plans, standard operating procedures, risk analysis, design control documents, drawings and specifications are generated in compliance with Integra's procedures, cGMP requirements and statutory requirements (US FDA, ISO, MDD and CMDR).
- Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required
- Identify and implement opportunities for continuous improvement.
- Perform other Quality Systems related duties, product development duties and sustaining product duties as required.
DESIRED MINIMUM QUALIFICATIONS / EXPERIENCE
? Preferably degree qualified ( Science or Engineering) but equivalent industry experience will be considered
? Must have 2+ years recent experience in quality assurance within the medical devices industry
? Manufacturing process knowledge
? Process validation experience required
? Good working knowledge of FDA Quality System Regulation and ISO13485, ISO14971
? Must have good interpersonal skills and ability to work at all levels within the organization
If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact me on
To find out more about Real please visit www.realstaffing.com