Quality Engineer III at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Verification Activities, Risk Management, Quality Systems, Documentation Practices, Analytical Techniques, Problem Solving, Statistical Analysis, Microsoft Office, Manufacturing Support, Cross-Functional Team Leadership, Project Management, Communication Skills, Nonconformance Investigation, Equipment Qualification, Test Method Validation

Industry

Medical Equipment Manufacturing

Description

Your Responsibilities Will Include: Responsible for understanding nonconformance scope, implementing product/process controls, and determining release criteria. Responsible for investigating nonconformances and writing required documentation. 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. 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 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

The Quality Engineer III is responsible for understanding nonconformance scope, implementing product/process controls, and determining release criteria. This role includes investigating nonconformances, performing process validation and verification activities, and supporting product development and manufacturing to meet compliance requirements.