Software Engineer I Quality Assurance
hace 7 días
**About the Role:**
We are seeking a highly skilled Quality Engineering Specialist to join our team at Boston Scientific Corporation. In this role, you will provide Quality Engineering support to commercial and development products, ensuring delivery of the highest quality results to customers while supporting continuous improvement projects and quality initiatives.
You will partner with R&D, Post Market, Manufacturing Engineers for support, and with product development teams to ensure development of robust new products. This role will work in various functions, including design activities, risk management, post market surveillance, and CAPA.
Your Responsibilities Will Include:
- Performing process validation and verification activities and reviewing related documentation.
- Supporting other functional areas during validation activities.
- Reviewing and approving technical drawings, procedures, and protocols.
- Participating in projects to identify root cause and implement corrective and preventive actions.
- Participating in understanding nonconformance scope, implementing product stops, and determining release criteria.
- Responsible for investigating nonconformances and writing required documentation.
- Responsible for completing signal evaluations for assigned product areas.
- Understanding product quality plans, documents, and systems by reviewing product specifications, quality specifications, and working with quality systems.
- May be responsible for learning risk analyses and FMEAs.
- Supporting design controls or post market surveillance integration activities for acquired entities.
- Collects and analyzes process defect data for product/process improvement efforts (e.g. nonconforming events, customer complaints).
Required Qualifications:
- Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
- English Level required: B2:(70-79%).
- 1 year or more in current position.
Preferred Qualifications:
- Knowledge of basic Quality System and good documentation practices.
- Experience in medical device industry in a Quality or R&D role.
- Self-starter with ability to identify improvement opportunities.
- Comfort speaking to groups of individuals.
- Presentation skills that comfortably and concisely translate performance and issues to peers.
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, Teams, and Outlook.
- Familiarity with product documentation, inspection and testing.
- Desired knowledge: understanding of inspection techniques and statistical methods, scientific tools (e.g. Gage R&R, DOE, process capability).
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