Supplier Quality Engineer III - Cardiac Rhythm Management

Supplier Quality Engineer III - Cardiac Rhythm Management

Work mode:
Hybrid Onsite Location(s):
Arden Hills, MN, US, 55112 Recruiter:
Spencer Gregory Hale Supplier Quality Engineer III – Cardiac Rhythm Management The External Operations organization focuses on Sourced Finished Medical Device (SFMD) at Boston Scientific and is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer III will demonstrate a primary commitment to patient safety and compliance through collaboration with cross-functional internal/external resources to continually improve our supplier's manufacturing processes to ensure finished device quality.

In this role, you will support SFMD products within the Cardiac Rhythm Management division with a primary focus on Single-Use Devices and Capital Equipment. Additionally, the Supplier Quality Engineer will support global sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Function or Divisional Overview At Boston Scientific, our products and technologies support the diagnosis and treatment of a wide range of medical conditions, with a focus on advancing less invasive care. Within the Cardiac Rhythm Management (CRM) portfolio, Boston Scientific develops, manufactures, and markets solutions designed to treat complex cardiac arrhythmias and enable precise, catheter-based interventions. The CRM portfolio includes technologies for cardiac mapping and navigation, radio frequency ablation, diagnostic electrophysiology, CRM recording systems, and intracardiac access and steerable sheath solutions, supporting physicians across the full CRM procedure workflow.

These products are designed to improve procedural efficiency, precision, and patient outcomes in the treatment of cardiac rhythm disorders. Boston Scientific continues to invest in innovation, clinical research, and global expansion within Cardiac Rhythm Management, extending access to advanced therapies across key geographies. Through ongoing portfolio development and clinical evidence generation, the CRM division supports the evolution of catheter-based treatment strategies for some of the most complex and prevalent cardiac arrhythmias.

Key Responsibilities will include:
New Product Development:
Core team member to support product launch through execution of SFMD Plan deliverables for integration and/or onboarding of supplier and related products into BSC's Quality System. Lead 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, process validations, and incoming inspection requirements.

Lead and support initial on-boarding assessments, new manufacturing locations and supplier's approved status Sustaining Supplier Quality & Compliance Responsible for ongoing supplier qualification and performance monitoring based on supplier risk. Assess suppliers for technical, quality and manufacturing capabilities 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 Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design Assurance.

Investigates & solves non-conformances due to product realization, product performance, incoming inspection, audit findings, & field failures related to supplier materials. Develop corrective action plan where necessary. 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 Supports supplier change impact assessments, 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.

Quality record ownership requiring technical writing skillset to formally document investigations, testing and verification of effectiveness actions utilizing statistical and industry standard quality tools Quality System Champion:
Supports…