Junior Quality Engineer

The Junior Quality Engineer is responsible for the support of daily activities to maintain the quality management system, including supporting incoming inspection, calibration process, training, complaint handling, supplier quality, etc., and ensure quality standards, processes, and procedures are in compliance. The Junior Quality Engineer will also participate in cross-functional projects supporting quality and process improvement initiatives. The Junior Quality Engineer also helps to ensure Nobel Biocare’s continued regulatory compliance in accordance with the FDA CFR 820, ISO 13485:2016 and MDSAP (Medical Device Single Audit Program) and the Medical Device Regulations in the EU (MDR).

Accountabilities –

• Ensure exceptional service for internal customers
• Follow all procedures (SOPs) and documentation related to the Quality Management System to ensure compliance to all standards
• Support the development, revision and maintenance of procedures, documentation and standards, relevant to the Quality Management System (Incoming inspection, training, calibration, etc.) that ensure best practices and compliance
• Assist in the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, product performance, etc.
• Support complaint investigations and documentation activities under the guidance of senior quality personnel, according to the medical device regulations; FSA 21 CFR Part 820 and ISO 1348:2016, leading to process/product improvements
• Assist in implementing process improvements by using problem solving techniques, such as Problem-Solving Process (PSP), Variation Reduction (VRK) and continuous improvement techniques such as Value Stream Mapping (VSM), Transactional Process Improvement (TPI), and Lean/Six Sigma
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
• Lead and/or support CAPA investigations and related corrective and preventive actions
• Ensure training support and effectiveness for multiple functions throughout the organization
• Partner with functional teams to support maintenance of the QMS training program per regulatory requirements
• Assist in the reporting of effectiveness of the Quality Management System
• Provide support for internal and external audits and inspections
• Assist in ensuring department goals and objectives are reached
• Report the status of the Quality Management System and other related issues on a regular basis to the Sr. QA Engineer and/or Quality Assurance Manager
• Other duties as assigned by the Quality Assurance Manager