Sr. Supplier Quality Engineer

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Sr. Supplier Quality Engineer

Newark, DE, United States

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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.

Knowledge

• 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.)

Skills

• 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)

Behaviors

• 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

Experience

• 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

Why join Hologic?

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.

Agency and Third-Party Recruiter Notice

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.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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