Quality Engineer III

Boston Scientific • Maple Grove, MN

50d • Onsite

About The Position

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. 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. This role will support the Access and Delivery Solutions Assembly (ADSA) Business Unit within Maple Grove Operations. At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week. Relocation assistance is not available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Requirements

• Bachelors of Science in Engineering or Science Related field
• Minimum of 3 years of relevant experience, specifically working with Process Validation and Verification activities and risk management documentation such as Design/Process FMEAs

Nice To Haves

• 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
• Knowledge of basic Quality Systems and good documentation practices
• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Number of Employees: 5,001-10,000 employees