Senior Supplier Quality Engineer- SFMD Endoscopy at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

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

Supplier Quality Engineering, Problem Solving, Corrective Action Plans, Process Validation, Design Controls, Risk Management, CAPA, Project Management, Manufacturing Support, Communication, Quality Systems, Technical Discussions, Supplier Management, Non-Conformance Investigation, Process Improvements, Documentation Changes

Industry

Medical Equipment Manufacturing

Description

Sustaining Engineering: 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. Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System. Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers. Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing related. Lead investigations into supplier-related nonconformances and implement effective Corrective and preventive actions (CAPA) Provide manufacturing support at external vendors by addressing manufacturing process defects and implementing process improvements utilizing Quality System tools. Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates. Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process. Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. BS degree in engineering or technical field with minimum of 5 years of relevant experience in supplier engineering, supplier management, or supplier quality engineering. Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. Experience with capital equipment or electronics including product development, servicing, and repair. Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing. Experience in process validation, design controls, risk management, CAPA, SCAR. 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 25%. Note: COVID-19 precautions currently restrict travel. 7+ years of medical device engineering experience preferred. 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.

Responsibilities

The Senior Supplier Quality Engineer evaluates and communicates quality issues to suppliers, applying systematic problem-solving methodologies. They lead investigations into supplier-related nonconformances and implement effective corrective and preventive actions.