Summer Intern - Quality Engineer (175603BR)
- Develop and/or implement design quality-related processes in a medical design/manufacturing environment.
- Participate and support the alignment of actions with OEM partners; initiate change orders (DCOs, PCOs, MOCs, and PCNs) as appropriate.
- Use risk management techniques for design and manufacturing and in vitro / medical device industries.
- Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers’ specifications/requirements for products.
- Support supplier qualification, development and monitoring activities to ensure that products meet design and manufacturing requirements as part of Design Transfer and quality system sustainability (production, operations, supplier quality processes).
- Advise and evaluate product verification/validation activities.
- Evaluate and implement protocols and methods and procedures to ensure that incoming material and manufactured products are compliant with internal requirements as well as to standards/regulations for worldwide distribution.
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Use Key Process Indicators (KPIs) or metrics to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
- Participate in continuous improvement efforts, such as practical process improvement (PPI).
- Support cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement.
- Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.
- Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.