Sr. Supplier Quality Engineer

Hologic•Newark, DE

About The Position

The Senior Supplier Quality Engineer is responsible for supporting the Supplier Quality organization by overseeing components, materials, and services provided by suppliers. This role ensures that suppliers meet all regulatory and quality requirements, collaborates with internal teams, and drives continuous improvement in supplier performance.

Requirements

Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001
Quality System Regulation and risk management
Validations (IQ, OQ, PQ) and root cause analysis (CAPA process)
Project management techniques
Measurement system analysis (GR&R, AAA)
Statistical Process Controls (SPC) and statistical sampling
Effective written and verbal communication at all organizational levels
Proficiency in problem-solving tools (SPC, TQM, etc.)
Analytical skills to evaluate data and situations, translating them into actionable plans
Ability to communicate ideas and approaches through proposals, plans, and presentations
High proficiency with Microsoft Office suite for reporting and data analysis
Ability to manage multiple complex projects simultaneously
Ability to work independently and collaboratively
Proficiency in English (written and oral); a second language is a plus
Minimum of 5 years of professional experience in similar roles with responsibility for decision-making and problem-solving
Recognized expertise within a similar organization
Bachelor’s degree in an engineering field (specific discipline may vary based on business needs)