Sr. Supplier Quality Engineer at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Apr, 26

Salary

0.0

Posted On

15 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supplier Quality Management, Project Management, Problem Solving, Quality Assurance, Process Validation, Design Controls, Risk Management, CAPA, Communication, Software Applications, Medical Device Experience, Leadership, Auditing, Regulatory Compliance, Change Management, Investigation

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Coordinates overall quality system project by tracking progress on project implementation, driving meetings to ensure timely completion and review, and developing communications for QMS updates Support on-going CAPA(s) and associated QMS implementation. Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Coordinates the evaluation of proposed changes at suppliers. Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Acquired Entity Quality system, the hybridized BSC-Acquired Entity Quality System, and in the BSC Quality System after products are successfully integrated. Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers. Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues. Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related. Supports Supplier Change Impact Assessments for process changes at suppliers. Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates. Execute initial onboarding deliverables to support initial distribution of Acquired Entity's products through BSC Distribution Centers. Execute SFMD Plan deliverables for integration of acquired company's suppliers and products into BSC's Quality System. Supports Material Controls external regulatory body audits requests as required. Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. BS degree in engineering or related technical field with 6+ years of relevant experience. Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing. 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). 8+ years of medical device engineering experience preferred. Experience driving large scale procedural updates. 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 plus

Responsibilities

The Sr. Supplier Quality Engineer will collaborate with corporate and regional supplier quality organizations to develop policies and guidelines, while also managing quality system projects and addressing quality issues with suppliers. They will support ongoing CAPA implementation and investigate non-conformances related to supplier quality.