Senior Quality Engineer at Boston Scientific Corporation Malaysia

, , Netherlands -

Full Time

Start Date

Immediate

Expiry Date

03 Mar, 26

Salary

0.0

Posted On

03 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Standards, Problem Solving, Continuous Improvement, Quality Engineering Practices, Analytical Skills, Teamwork, Project Management, Risk Management, Data Analytics, Communication Skills, Medical Device Industry, Regulatory Requirements, ISO Standards, cGMP, Supply Chain Distribution, Lean Initiatives

Industry

Medical Equipment Manufacturing

Description

Pro-actively demonstrate leadership and seniority in the implementation of all Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements Monitors and interprets process signals to detect early quality risks and initiates timely actions to prevent deviations and ensure process robustness Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues. Pro-actively implements Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements. Understands and applies quality principles to support an effective overall quality system. Act as a team member in continuous improvement activities, NCEPs, CAPA and lean initiatives from a quality perspective, for both internal and external customers. Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/manages improvement projects within the organization (VIP, QMP, Star, Lean, 5S). Understands and utilizes problem solving methodologies; (CAPA, Is/Is not diagram/Fishbone diagram, Pareto, FMEA). Actively participates in Strategic and site projects. Acts as the Quality Core Team member is a dedicated area or project. Coaches more junior team members in specific Quality systems and processes. Flexibility to perform general QA related activities. Support and prepare for site level internal and external audits and act as Subject Matter Expert (SME) in audits. Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes. The Sr Quality Engineer may be required to support BSC activities & processes at our 3PL when required. 5+ years' experience with Bachelor's Degree or equivalent in a manufacturing environment Comprehensive understanding of the MDD/EU MDR, ISO standards and cGMP Demonstrates knowledge in teamwork, SAP, project management, problem solving and risk management techniques Effective team member, fully motivated to achieve and demonstrate best practices in line with the department & global objectives Good social and communication skills Proficient in AI and data analytics for quality processes Strong analytical skills, eager to improve and results oriented Good knowledge of the English language (verbal and written) Experience with supply chain distribution and packaging Medical device industry experience Does this position sound like the next step in your career? Join a team that works together to find solutions that make a difference! Requisition ID: 619715 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Responsibilities

The Senior Quality Engineer will lead the implementation of Quality standards and procedures to ensure compliance with Corporate and Regulatory requirements. They will monitor process signals for quality risks and engage in continuous improvement initiatives.