Boston Scientific is looking to provide Quality Engineering support to manufacturing lines ensuring the delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives.
Requirements
- Minimum of 3 years of relevant experience, specifically working with Process Validation and Verification activities and risk management documentation such as Design/Process FMEAs
- Knowledge of basic Quality Systems and good documentation practices
- Knowledge of analytical techniques, problem solving and statistical analysis
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
- Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System
Responsibilities
- Lead or participate in projects to identify root cause and implement corrective and preventive actions.
- Responsible for understanding nonconformance scope, implementing product/process controls, and determining release criteria. Responsible for investigating nonconformances and writing required documentation.
- Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design.
- Perform process validation and verification activities and review related documentation
- Support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Develop and update risk management deliverables
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
Other
- Bachelors of Science in Engineering or Science Related field
- Experience in medical device field in a manufacturing support role a plus
- Experience in quality line support
- Good written and verbal communication skills.
- Must be able to work independently under limited supervision
