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Design Quality Assurance Engineer II - Urology at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Usability Engineering, Problem Solving, Quality Assurance, Risk Management, ISO 13485, ISO 14971, Quality System Regulations, Communication Skills, Teamwork, Medical Device Industry, Regulatory Audits, Post Market Activities, Dynamic Environment, 5 Whys Analysis, DMAIC, Is-Is Not Analysis

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6). Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues in a timely manner. Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals. Support internal and external regulatory audits as required. Minimum of a Bachelor's Degree in mechanical, electrical, or biomedical engineering (or other related technical discipline). Minimum of 2 years of related experience. Travel approximately

Responsibilities

Support Usability Engineering and planning documentation, applying systematic problem-solving methodologies to resolve quality issues. Ensure products meet performance and quality expectations through risk-based assessment and support regulatory audits.