Principal Quality Engineer at Boston Scientific Corporation Malaysia

Kerkrade, Limburg, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Internal Audits, FDA Compliance, ISO Standards, EU MDR, Continuous Improvement, Coaching, Mentoring, Problem-Solving, Cross-Functional Collaboration, Analytical Skills, Process Management, Lean, 5S, GMP, Medical Device Manufacturing

Industry

Medical Equipment Manufacturing

Description

Implement, maintain, and improve the Kerkrade Quality Management System. Responsible for working with Quality management, department personnel and other areas on process reviews and implementation of requirements to ensure site audit readiness Ensures Annual Global Quality Systems Objectives and Metrics are understood and achieved in line with BSC Best Quality Strategy. Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, EU MDR, and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. Drive continuous improvements in the distribution center Act as a coach/ mentor to aid development of junior staff members Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, VIP, QMP, StAR, Lean, 5S). Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally & externally. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes. Is viewed as a leader in the areas of QSR and ISO/MDR standards within one's own group, constantly promoting awareness of best industry practices making appropriate decisions using the Site QA Associate Director and Quality Systems Manager as the final arbitrator on critical quality decisions. 5+ Years lead auditor experience 5+ Years relevant experience in a GMP Medical Device Manufacturing environment Experience in a Distribution center is a plus. Green Belt certified (is a plus) with process management experience Familiar with quality tools and problem-solving techniques Team player with strong work ethic and positive mentality Computer literate Good social and communication skills Strong analytical skills, "self-starter" and eager to improve English language proficiency 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: 609337 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

Implement, maintain, and improve the Kerkrade Quality Management System while ensuring site audit readiness. Plan and conduct internal audits to assess compliance with various standards and drive continuous improvements in the distribution center.