Quality Engineer II

The Quality Engineer II (QE II) is a leader within Quality Operations responsible for driving quality strategy, managing risk, and ensuring regulatory compliance across manufacturing operations at the Melville site. This role leads complex investigations, advances risk mitigation and continuous improvement initiatives, and provides technical oversight across quality systems, validation, and new product launches. In addition to individual contributions, the QE II serves as a people manager, developing and leading a team, while strengthening technical capabilities in data analysis, statistical problem-solving, and quality engineering practices. The QE II operates with a high degree of independence, influencing cross-functional and global initiatives to ensure sustainable process performance and a strong culture of quality.

Responsibilities

Drive quality strategy, manage risk, and ensure regulatory compliance across manufacturing operations; Lead complex investigations; Advance risk mitigation and continuous improvement initiatives; Provide technical oversight across quality systems, validation, and new product launches; Serve as a people manager, developing and leading a team; Influence cross-functional and global initiatives; Lead quality investigations, CAPA & risk leadership; Provide work center, manufacturing & packaging technical oversight; Conduct advanced data analysis, continuous improvement & QE projects; Lead New Product Launch (NPL), Validation & Process Excellence; Support GMP, Compliance & Audit Leadership; Provide people leadership & mentorship

Requirements

Minimum Bachelor of Science degree in Engineering or Science, or equivalent experience (10+ years in a related field); 5+ years QE experience in a fast-paced regulated manufacturing environment; 5% Travel

Nice to have

ASQ or Lean Certification

Benefits

Highly competitive bonus program; Health insurance coverage (medical, dental, and vision insurance); Wellness and family support programs; Life and disability insurance; Retirement savings plans; Paid leave programs; Education-related programs; Paid holidays and vacation time