Job Description

Location:Penang -Salary:CompetitiveType:PermanentMain Industry:Other Industries & Skills:Aerospace ManufacturingAdvertiser:Job ID:130553886Posted On:25 May 2024Additional Locations: Korea-Kangnam-guDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we\xe2\x80\x99ll give you the opportunity to harness all that\xe2\x80\x99s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we\xe2\x80\x99ll help you in advancing your skills and career. Here, you\xe2\x80\x99ll be supported in progressing \xe2\x80\x93 whatever your ambitions.Purpose StatementThe Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our contract manufacturer and OEM supplier\xe2\x80\x99s manufacturing processes.Key ResponsibilitiesNew Product Development:style="margin-bottom:11.0px"-
-Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers
-Generate and review quality plans, agreements, product specifications, component qualifications, and process validations
Sustaining Engineering:style="margin-bottom:11.0px"-
-Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation
-Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers
-Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions
Quality System Champion:style="margin-bottom:11.0px"-
-Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents
-Identifies and advises management on potential improvements to quality systems and processes in the company
-Champions 100% compliance to company policies and SOP\xe2\x80\x99sKey Qualificationsstyle="margin-bottom:11.0px"-
-Fluency in English
-BS degree in engineering or related technical field with 4+ years of relevant experience in the medical device industry
-Project management experience: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing
-Relationship building focused: ability to collaborate and build strong relationships with suppliers
-Experience in process validation, design controls, risk management, and CAPA
-Ability to work independently; organized and self-driven
-Articulate communicator; adept at packaging and appropriately scaling information to the intended audience
-Ability to rapidly learn and use new software applications (e.g., PLM, ERP)
-Domestic and international travel up to 20%Preferred Qualificationsstyle="margin-bottom:11.0px"-
-7+ years of medical device engineering experience is preferred
-Experience in the automotive, aeronautical, semiconductor, or other regulated industry
-Leadership experience on a materials or service commodity team
-Lead auditor of quality systems experience (ISO 13485 or similar)
-ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired
-Medical Device OEM Supplier Quality Management is a plusRequisition ID: 583844As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most \xe2\x80\x93 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 those values to everything we do \xe2\x80\x93 as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific (NYSE: BSX) isn\xe2\x80\x99t just business, it\xe2\x80\x99s personal. And if you\xe2\x80\x99re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you and look forward to connecting with you!

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