Supplier Quality Engineer III - External Operations CRM/NMOD

Boston Scientific • Arden Hills, MN

3h

About The Position

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, defines complaint management processes and 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.

Requirements

• BS degree in engineering or technical field
• 5+ years of relevant experience
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry
• Project management skills
• Experience in process validation, design controls, risk management, CAPA, SCAR
• Ability to work independently
• Articulate communicator
• Ability to rapidly learn and use new software applications
• Domestic and international travel up to 25%

Nice To Haves

• 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

• Evaluates and communicates quality issues to suppliers
• Applies problem-solving methodologies to resolve quality issues
• Reviews and approves supplier corrective action plans
• Proactively assesses supplier capabilities through on-site visits
• Coordinates the evaluation of proposed changes at suppliers
• Manages sustaining quality issues and process change impacts
• Investigates and solves non-conformances
• Supports Design Quality Assurance with post market surveillance
• Investigates complaints and manages NCEPs at suppliers
• Supports Supplier Change Impact Assessments
• Supports and performs Finished Good Documentation changes
• Creates, defines and manages Inspection Plans
• Leads projects and hits project milestones
• Executes SFMD Plan deliverables
• Supports Material Controls external regulatory body audits
• Collaborates with corporate and regional supplier quality organizations

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees