Manager, Supplier Quality - Bracco Medical Technologies

Bracco Medical Technologies•Eden Prairie, MN

2d•$132,000 - $144,000•Hybrid

About The Position

Leads Bracco Medical Technologies' Supplier Quality Management program and Receiving Inspection function to ensure externally supplied materials meet quality, regulatory, and business requirements. Responsible for supplier qualification, audits, performance management, incoming inspection, supplier CAPA, and continuous improvement while ensuring compliance with FDA Quality System Regulations, ISO 13485, ISO 14971, MDR, and applicable GMP requirements. Partners cross-functionally to reduce supplier risk, improve supplier performance, and support product commercialization.

Requirements

Bachelor's degree in Engineering, Quality, Manufacturing, Supply Chain, or related discipline.
5+ years of Supplier Quality or Quality Engineering experience in a regulated manufacturing environment.
Leadership experience managing technical teams.
Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, MDR, MDSAP, GMP.
Experience with supplier audits, CAPA, FMEA, SPC, Lean, Six Sigma, and AQL sampling.
Ability to travel domestically and internationally (20–40%).

Nice To Haves

Medical device industry experience.
ISO 13485 Lead Auditor, ASQ CQE/CQA, or Lean Six Sigma certification.
Experience leading Receiving Inspection and FDA/Notified Body inspections.
Strong leadership, communication, and project management skills.
Excellent analytical and root cause problem-solving abilities.
Self-motivated with a continuous improvement mindset.

Responsibilities

Lead Supplier Quality Management, supplier qualification, approval, monitoring, and requalification.
Manage Receiving Inspection operations, personnel, priorities, and competency development.
Conduct supplier audits, risk assessments, and establish Quality Agreements.
Monitor supplier KPIs, scorecards, and drive continuous improvement initiatives.
Lead supplier nonconformance investigations, MRB activities, Root Cause Analysis, and CAPA.
Develop incoming inspection plans using risk-based sampling (AQL), FAI, and statistical methods.
Ensure incoming materials comply with FDA, ISO 13485, GMP, and product specifications.
Oversee calibration and compliance of inspection and metrology equipment.
Partner with Sourcing, Operations, Engineering, RA, Product Quality, and NPD to mitigate supplier risk.
Manage and lead the material review board for Operations including data generation and analysis, meeting execution, any follow up activities, meeting minutes, and filing of all MRB records.
Support internal, customer, and regulatory audits while maintaining supplier quality documentation.