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Design Assurance Quality Engineer - P2 at Boston Scientific Corporation Malaysia
Cork, Munster, Ireland -
Full Time

Start Date

Immediate

Expiry Date

05 Feb, 26

Salary

0.0

Posted On

07 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Design Controls, Risk Management, Usability, Statistical Analysis, Root Cause Analysis, Problem Solving, Analytical Skills, Quality Management Systems, Validation Techniques, Post Market Surveillance, EU MDR, IEC 62366-1, Collaboration, Communication Skills, Critical Thinking, Engineering Analysis

Industry

Medical Equipment Manufacturing

Description
General Be a part of extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements. Develops understanding of Design Controls, Risk Management and Usability for Medical Devices. Supports departmental, functional, and divisional Design Quality goals and priorities. Executes methodologies to meet individual and team objectives effectively. Execute methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities. Apply critical thinking and engineering analysis to solve problems. CAPAs, VIPs, and regulatory requirement changes. Analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data. Minimum of a Honours bachelor's degree (Level 8) in engineering (Biomedical, Mechanical, Electrical, etc.) or equivalent fields of study. 2+ years of experience in design assurance or a related field, or a combination of education and experience to perform at this level. Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems). Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management. Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills. Experience with Post Market Surveillance, EU MDR, and IEC 62366-1 (Usability). Ability to work independently and as part of a team.
Responsibilities
Be part of an extended project team to implement effective controls for product development and maintenance. Support departmental and divisional Design Quality goals through methodologies like Statistical Analysis and Risk Management.