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Design Quality Engineer II at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Feb, 26

Salary

0.0

Posted On

21 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Problem Solving, Design Control, Risk Management, Quality Assurance, Medical Devices, Compliance, Communication, Collaboration, Usability Testing, Design Reviews, CAPA, FMEA, SW Validation, Process Validation, Task Analysis, Design V&V

Industry

Medical Equipment Manufacturing

Description

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Develops and executes plans for design control and risk management of complex projects Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Working knowledge of Design Controls. Provide design quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling). Promotes and influences compliance to BSC's quality, business and health & safety systems and market/legal regulations Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure. Bachelor's degree in engineering or science discipline, or equivalent. 3+ years experience in design assurance, quality, or related medical device or regulated industry experience Knowledge of basic Quality System Requirements and Good Documentation Practices High energy problem solver capable of driving items to closure. Adaptable and effective collaborator in a team environment and in self-directed work Strong communication skills (verbal & written) Experience with Class III Medical Devices Experience with Capital Equipment Experience with design control, risk management, and medical device standards compliance Experience with corrective and preventive action

Responsibilities

The Design Quality Engineer II applies systematic problem-solving methodologies to identify and resolve quality issues while developing plans for design control and risk management. They provide quality and compliance input to project teams and ensure adherence to quality policies and regulations.