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Quality Engineer II at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Mar, 26

Salary

0.0

Posted On

17 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Problem Solving, Quality Assurance, Manufacturing Engineering, Root Cause Analysis, Process Validation, Statistical Sampling, CAPA, Risk Management, Supplier Quality, Non-Conforming Material Review, Medical Device Regulation, ISO 13485, Team Collaboration, Mentorship, Documentation, Inspection

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Collaborate with technicians and manufacturing engineers in assisting in identification of manufacturing process defects, identification of primary root causes, understanding corrective and preventative actions, and dispositioning non-conforming material. Perform process validation and verification activities, including test method validation, and generate/review related documentation. Participates in team decision making and displays team problem solving/communication skills. Working with Project Management and Division teams to support new and updated products added to the area Process ownership and MRB support Provide support and mentorship to area Quality Technicians Bachelor's degree in engineering or science related field Minimum 2 years experience in an engineering or science related field Experience in a regulated medical device industry, preferably in Quality Experience in an operations setting Experience in Capital Equipment manufacturing Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering Prior experience with non-conforming material review process Experience in Validation, Statistical sampling and/or Root Cause Investigation Familiarity with product documentation, inspection and testing, and Manufacturing Execution Problem Solving Certification (Green Belt, CQE, Six Sigma, etc.). Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards

Responsibilities

The Quality Engineer II will apply systematic problem-solving methodologies to identify and resolve quality issues while collaborating with technicians and manufacturing engineers. Responsibilities also include performing process validation and verification activities and providing support and mentorship to Quality Technicians.