Supplier Quality Engineer III - External Operations URO at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Jan, 26

Salary

0.0

Posted On

01 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supplier Quality Engineering, Problem Solving, Project Management, Medical Device Experience, Process Validation, Design Controls, Risk Management, CAPA, SCAR, Inspection Plans, Continuous Improvement, Communication, Technical Discussions, Quality Systems, Audits, Leadership

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 for suppliers within the BSC quality system requirements as well as supporting any requirements from the supplier's Quality system. Investigates and solves non-conformances due to product realization, product performance, incoming inspection, audit findings, etc. Supports Design Quality Assurance with post market surveillance, trending Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues. Investigates complaints, define complaint management processesand manages NCEPs at OEM suppliers, CM suppliers and other categories of 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. Creates, defines and manages Inspection Plans for finished devices in BSC Distribution Centers Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process. Leads and/or supports continuous improvement opportunities to drive efficiency and effectivity at BSC points of use. Execute SFMD Plan deliverables for integration and/or onboarding of supplier and related 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%. 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 III evaluates and communicates quality issues to suppliers, applying systematic problem-solving methodologies. They manage sustaining quality issues and support design quality assurance with investigations on supplier-related quality issues.