Sr. Supplier Quality Engineer

United States·Newarksenior

Supplier Quality EngineerProcurement & Purchasing

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Quick Summary

Overview

The Senior Supplier Quality Engineer is responsible for supporting the Supplier Quality organization by overseeing components, materials, and services provided by suppliers.

Technical Tools

ms-officeagiledata-analysisproject-management

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.

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
PPAP (Production Part Approval Process) knowledge (desirable)
Familiarity with applicable regulations (FDA, Canada, Brazil, Japan, etc.)

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
ISO 13485 lead auditor certification (preferred)
Proficiency in English (written and oral); a second language is a plus
Familiarity with tools such as Project, Visio, MiniTab, and Agile (desirable)

Collaborative approach with suppliers and internal teams
Strong organizational and follow-up skills
Commitment to continuous improvement and regulatory compliance
Willingness to travel domestically and internationally as needed
Adherence to safety protocols, including wearing safety shoes in designated areas

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)
ASQ Supplier Quality Engineer Certificate is a plus

What We Offer

~1 min read

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $98,500 - $154,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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