Quality Engineer III

Quality Engineer III

Work mode: Onsite

Onsite Location(s): Maple Grove, MN, US, 55311

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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 Metals Core Technology (MCT) 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 at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

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

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.