Quality Engineer II Job

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

About This Role:

Provide Quality Engineering support to Maple Grove commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. Partner with production and manufacturing engineers for operations support, and with product development teams to ensure development and introduction of robust new products.

This role will support the Core Technology Polymers (CTP) Business Unit within Maple Grove Operations.

Your Responsibilities Will Include:

• Develop and updating risk management deliverables

• Perform process validation and verification activities and review related documentation for new product introductions

• Lead and support Test Method Validation activities
• Lead or participate in projects to identify root cause and implement corrective and preventive actions.
• Responsible for understanding nonconformance scope, implementing product stops, and determining release criteria. Responsible for investigating nonconformances and writing required documentation.
• Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation to reduce/eliminate the cause of defects.

What We’re Looking For In You:

Minimum Qualifications

• BS with 2 or more years of relevant experience, specifically working with Process Validation and Verification activities and risk management documentation such as Design/Process FMEAs
• Good written and verbal communication skills.
• Must be able to work independently under limited supervision
• Knowledge of basic Quality Systems and good documentation practices

Preferred Qualifications

• Experience in medical device field in a manufacturing support role a plus
• Self-starter with the ability to identify improvement opportunities
• Experience leading cross-functional teams and driving projects to completion.
• Demonstrated experience managing multiple projects covering diverse engineering (i.e. equipment qualification, process validation, test method validation) disciplines.
• Prior interactions with the following disciplines: manufacturing engineering, CAPA, risk management, supplier quality, and process engineering
• 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 (MES)
• Bachelor’s Degree with engineering or science major

About Us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Requisition ID: 474819