Supplier QA Manager - Global Direct Packaging Materials

Boston Scientific•Arden Hills, MN

About The Position

1. Provide hands on quality support to global manufacturing and distribution centers in resolving packaging-related issues. Collaborate with incoming inspection, operations, and logistics to improve packaging robustness and process capability. Support continuous improvement projects focused on inspection reduction, material qualification, scrap reduction, shipping performance, and packaging optimization. Ensure supplier compliance with corporate and global regulatory requirements (ISO 13485, ISO 9001, EU MDR, FDA QSR). Maintain robust quality systems documentation for audits, supplier qualifications, SCARs, and risk management activities. Support internal and external audits with supplier related evidence, CAPA follow ups, and remediation actions. Promote best practice quality system behaviors across the supply base. Develop and implement the global supplier quality strategy for direct packaging materials. Lead, coach, and develop a global team of Supplier Quality Engineers, ensuring consistent capability, performance, and developmental growth. Serve as the packaging supplier quality SME for global sourcing, operations, R&D, and leadership teams.

Requirements

Bachelor's degree in Packaging, Mechanical, Materials Science, Biomedical or other Engineering related fields.
7+ years of related work experience in quality engineering
2+ years of experience leading or mentoring engineers or technical teams.
Excellent communication and cross-functional leadership skills.
Demonstrated experience developing and executing strategic plans or strategic objectives.
Technical knowledge of packaging materials, printing, labeling, sterile barrier systems, and related manufacturing processes
Experience in medical devices, pharmaceutical, or highly regulated industries.
Certifications such as ISO 13485/9001Certified Lead Auditor, Certified Manager of Quality / Organizational Excellence, CQE, CSQP, etc.
Skilled in quality tools: 8D, DMAIC, root cause analysis, SPC.

Responsibilities

Provide hands on quality support to global manufacturing and distribution centers in resolving packaging-related issues.
Collaborate with incoming inspection, operations, and logistics to improve packaging robustness and process capability.
Support continuous improvement projects focused on inspection reduction, material qualification, scrap reduction, shipping performance, and packaging optimization.
Ensure supplier compliance with corporate and global regulatory requirements (ISO 13485, ISO 9001, EU MDR, FDA QSR).
Maintain robust quality systems documentation for audits, supplier qualifications, SCARs, and risk management activities.
Support internal and external audits with supplier related evidence, CAPA follow ups, and remediation actions.
Promote best practice quality system behaviors across the supply base.
Develop and implement the global supplier quality strategy for direct packaging materials.
Lead, coach, and develop a global team of Supplier Quality Engineers, ensuring consistent capability, performance, and developmental growth.
Serve as the packaging supplier quality SME for global sourcing, operations, R&D, and leadership teams.