Senior Quality Engineer at Boston Scientific Corporation Malaysia

Cluain Meala, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

0.0

Posted On

15 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Process Controls, Process Acceptance Activities, Non-Conforming Product Controls, CAPA, Problem-Solving, Process Improvement, Engineering Essentials, Leadership, Communication, Manufacturing Process, Regulatory Compliance, Technical Investigations, Mentoring, Change Management, Stakeholder Communication

Industry

Medical Equipment Manufacturing

Description

Process & Quality Control Develop an in-depth understanding of the manufacturing process for Urology Scopes products, including all aspects of production and process controls. Develop and/or review Process Qualifications, Test Method Validations, Gage R&R studies, Process Capability studies, Design of Experiments (DOE), and production control plans. Lead and own change-related activities in support of new product implementation, including establishing site-specific systems and controls. Lead back-room activities and provide front-room support during external audits, ensuring the production unit remains audit-ready at all times. Ensure regulatory compliance in all projects by applying quality tools and processes. Coordinate and conduct technical investigations of non-conforming events using eCAPA and BSC Engineering Essentials. Lead investigations into internal and external customer complaints. Provide clear communication to stakeholders during key technical updates. Mentor and guide less experienced staff as required. Strong working knowledge of Quality Systems, particularly Production and Process Controls, Process Acceptance Activities, Non-conforming product controls, and CAPA. Proficient in problem-solving and process improvement methodologies (e.g., Engineering Essentials). Ability to plan, organise, and prioritise workload to meet deadlines. Strong interpersonal skills to influence peers and management. Level 8 honours degree in Engineering, Quality, or Science. Minimum 5 years' experience in a medical device or related regulated industry. Demonstrated leadership and communication skills. Preferred: Experience with eCAPA systems, BSC Engineering Essentials, and certifications such as Six Sigma or Lean.

Responsibilities

The Senior Quality Engineer will develop a deep understanding of the manufacturing process for Urology Scopes products and lead change-related activities for new product implementation. They will ensure regulatory compliance and coordinate technical investigations of non-conforming events while providing support during external audits.