Manager, Supplier Quality - Bracco Medical Technologies
Why Join Bracco Medical Technologies?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
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.Primary Duties & 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.
Qualifications (Knowledge, Skills & Abilities):
Minimum
- 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%).
Preferred:
- 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.
Other:
- Strong leadership, communication, and project management skills.
- Excellent analytical and root cause problem-solving abilities.
- Self-motivated with a continuous improvement mindset.
Compensation & Total Rewards:
Estimated Starting Salary Range: $132,000 - 144,000
*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.
Total Rewards:
Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.
Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.