Sr. Quality Assurance Engineer

Hologic • Newark, DE

103d • $94,000 - $146,900

About The Position

Join Hologic as a Senior Quality Assurance Engineer and play a critical role in designing, implementing, and maintaining quality assurance protocols that meet internal and external regulatory standards for worldwide distribution. In this role, you'll collaborate with cross-functional teams, lead quality initiatives, and drive continuous improvement to ensure the delivery of high-quality, innovative products that improve lives globally.

Requirements

• Bachelor's Degree in Electrical Engineering (preferred) with 2-5 years of experience, or Master's Degree with 1-3 years of experience, or PhD with 0-1 year of experience.
• In-depth understanding of quality management systems (QMS) and regulatory standards (e.g., GMP, GLP, ISO, FDA, Six Sigma).
• Strong knowledge of manufacturing, sterilization, and cleanroom processes.
• Experience in troubleshooting electrical failures (PCB's, cable wire harness assemblies, microchips).
• Demonstrated experience in quality assurance, quality improvement methodologies, and regulatory compliance.

Nice To Haves

• Certified Quality Engineer (CQE) certification.
• Experience with sterilization and cleanroom processes.
• Working knowledge of FDA and ISO regulations governing medical devices.

Responsibilities

• Design, implement, and maintain quality assurance protocols.
• Collaborate with cross-functional teams to ensure quality standards.
• Lead quality initiatives and drive continuous improvement.
• Ensure compliance with internal and external regulatory standards.
• Author quality assurance reports, procedures, and investigation protocols.
• Evaluate large datasets and identify trends for scientific conclusions.
• Plan, prioritize, and execute multiple projects within deadlines.

Benefits

• Comprehensive training upon joining and continued development throughout your career.
• Bonus eligibility based on performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees