Boston Scientific Quality Engineer III 

United States, Minnesota 

823033273

About This Role

Your Responsibilities Will Include:

• 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.

Required qualifications

• 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

Preferred qualifications

• 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

Maximum Salary: $ 144400

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.