Senior Quality Engineer at Boston Scientific Corporation Malaysia

Galway, Connacht, Ireland -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

0.0

Posted On

10 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, ISO 13485, 21 CFR 820, Problem-Solving, Stakeholder Management, SAP S/4HANA, Agile Methodologies, UAT Execution, Analytical Skills, Technical Writing, Software Validation, Digital Quality Systems, CAPA, Lean, Continuous Improvement, Audit Support

Industry

Medical Equipment Manufacturing

Description

Demonstrate strong commitment to the Quality Policy and compliance with 21 CFR Part 820, ISO 13485, and BSC Quality System requirements. Build quality into all aspects of work and support compliant solution design. Conduct quality impact assessments and execute Full Track CN approvals in Windchill. Apply effective problem-solving methodologies to resolve quality issues. Bachelor's degree in Engineering, Science, or related field. 5+ years of Quality Engineering or Quality Systems experience in a regulated environment. Ability to perform Full Track CN approvals in Windchill. Strong understanding of ISO 13485 and 21 CFR 820. Experience supporting process or system transformation initiatives. Excellent communication, documentation, and stakeholder management skills. Experience with SAP S/4HANA or large-scale ERP modernization. Experience with systems such as SAP, Salesforce, Coupa, or MDG. Knowledge of Agile methodologies and UAT execution. Strong analytical and technical writing skills. Software validation or digital quality systems experience. Systems thinker with strong analytical skills. Comfortable operating in ambiguity with ability to bring clarity. Strong relationship builder and collaborator. High accountability, professionalism, and attention to detail. Able to work effectively across functions and geographies. Analyze, document, and validate quality-related business requirements. Facilitate workshops to evaluate current-state and future-state workflows. Develop and execute UAT scripts, test plans, and traceability matrices. Ensure change control and documentation governance are upheld. Provide coaching and SME support to Quality Engineers and Technicians. Support CAPA, Lean, and continuous improvement initiatives. Audit & Quality Systems Support Support audit readiness and document non-conformances. Contribute to development of streamlined quality business systems.

Responsibilities

The Senior Quality Engineer will ensure compliance with quality policies and regulations while conducting quality impact assessments and executing Full Track CN approvals. They will also support CAPA, Lean, and continuous improvement initiatives.