Supplier Quality Engineer II - 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

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Problem Solving, Project Management, Medical Device Experience, Process Validation, Design Controls, Risk Management, CAPA, SCAR, Communication, Supplier Quality, Technical Discussions, Change Impact Assessments, Finished Good Documentation, ISO 13485, ASQ Certification

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. 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 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. 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. Execute SFMD Plan deliverables for onboarding of products into BSC's Quality System. Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers. Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. BS degree in engineering or technical field with minimum of 2 years of relevant experience in quality engineering. 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, CAPA, SCAR. 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%. 3+ years of medical device engineering experience preferred. Medical Device Industry experience Problem Solving and Project Management experience 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) desired.

Responsibilities

The Supplier Quality Engineer II evaluates and communicates quality issues to suppliers, applying systematic problem-solving methodologies. They manage sustaining quality issues and collaborate with cross-functional teams to onboard finished medical device suppliers.