Ecocareers ยท 3 months ago
Medical Device Supplier Quality Engineer
Arden Hills, MN
Full-time
Onsite
Entry, Mid Level
2+ years expBoston Scientific is a global team that oversees a diverse network of suppliers manufacturing finished devices for distribution. The Supplier Quality Engineer II will focus on ensuring patient safety and improving supplier manufacturing processes, particularly for Single-Use Devices and Capital Equipment accessories.
Staffing & Recruiting
Responsibilities
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
Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions
Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Relevant Quality system, the hybridized BSC-Relevant 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 Centres
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 labelling 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 integration of acquired company's suppliers and 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
Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations
Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents
Identifies and advises management on potential improvements to quality systems and processes in the company
Champions 100% compliance to company policies and SOPs
Qualification
Required
BS degree in engineering or technical field with minimum of 2 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
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%
Preferred
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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase