Quality Engineer II
About The Position
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.
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
Nice To Haves
- ASQ or Lean Certification preferred
Responsibilities
- Provide oversight and direction for consumer complaint, deviation, and quality inquiry (QI) investigations, and review investigation quality, trending, and effectiveness of corrective actions to prevent recurrence
- Lead complex, high-risk, and systemic investigations across manufacturing and packaging operations
- Apply advanced root cause analysis tools and ensure robust, risk-based CAPAs are developed and sustained
- Partner with site Quality leadership on significant quality issues originating within the Melville site
- Provide higher-level oversight and technical guidance for on-floor troubleshooting, manufacturing equipment challenges, and functional component issues
- Support escalation and resolution of quality-related disruptions impacting line efficiency and compliance
- Provide technical expertise in packaging components, design, manufacturing processes, and functional failure modes
- Work with suppliers, developers, Packaging Development, Commercialization Engineering, and Production teams to define and align critical quality requirements
- Serve as a site resource for statistical process control (SPC), data analysis, and advanced trending methodologies
- Conduct and oversee analysis of data to identify trends, loss drivers, and improvement opportunities
- Lead or sponsor quality engineering projects using statistical tools and structured problem-solving methodologies
- Lead critical site quality initiatives and act as the Melville Site QA representative on global and cross-functional programs
- Provide quality leadership and oversight for NPL activities, including component evaluations, line tests, first production runs, in-process inspections, and post-trial evaluations
- Guide dFMEA and pFMEA activities and broader process mapping and risk mitigation efforts
- Collaborate with Commercialization Engineering, Packaging Development, Supplier Quality, Brand Quality, and cross-functional teams to identify and mitigate risks early in the product lifecycle
- Provide quality oversight for equipment URS development, qualification, and process validation (IQ/OQ/PQ)
- Ensure appropriate packaging test methods are selected, developed, and implemented for new package designs, new technologies, and new or modified manufacturing lines, ensuring alignment with product requirements
- Serve as a GMP and compliance leader, ensuring activities align with internal procedures and global regulatory expectations
- Support internal audits and external inspections with strong technical and regulatory knowledge
- Act as a quality authority on documentation, procedures, technical reports, and quality records
- Drive audit readiness and compliance improvements across the site
- Support interpretation and application of regulatory requirements including FDA, ISO 22716, CSAR, and MFDS expectations
- Lead, coach, and develop a small team of QE I roles and/or Quality Specialists
- Strengthen team capability in data analysis, statistical thinking, structured problem solving, and quality engineering practices
- Set priorities, allocate workload, and drive accountability for quality performance and deliverables
- Provide technical mentorship and act as an escalation point for complex quality, validation, and risk issues
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
