Sr. Supplier Quality Engineer - Direct Materials Acquisitions at Boston Scientific Corporation Malaysia

, , United States -

Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

0.0

Posted On

09 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supplier Quality Engineering, Problem Solving, Project Management, Process Validation, Design Controls, Risk Management, CAPA, SCAR, Communication, Technical Discussions, Quality Systems, Auditing, Medical Device Industry, Manufacturing, Regulatory Compliance, Change Management

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. 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. Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers. 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. Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process. Support manufacturing lines of acquired entity's manufacturing line through 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 technical field with minimum of 5 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, 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%. 7+ years of medical device engineering experience preferred. Medical Device Industry experience Drug or animal tissue 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 Sr. Supplier Quality Engineer evaluates and communicates quality issues to suppliers, manages sustaining quality issues, and supports design quality assurance. They lead projects, create project plans, and assess supplier capabilities through on-site visits.