Senior Quality Engineer-ClorDiSys

Allentown LLC • Branchburg Township, NJ

10h • Onsite

About The Position

The Senior Quality Engineer serves as a key leader within the Quality organization, responsible for driving data driven decision‑making, ensuring regulatory compliance and strengthening the company’s quality systems.  This role oversees the data analysis and continuous process verification program, leads the AI‑based predictive analytics initiative and manages some of the critical quality system processes including non‑conformance, CAPA and external standards compliance. The Senior Quality Engineer ensures that all activities align with cGMP, QMSR, ISO 13485 and ISO 14971 requirements while supporting operational productivity, safety and sterilization service and manufacturing quality.

This position requires deep expertise in quality engineering within a GMP environment, advanced proficiency in data analytics using tools such as Minitab and the ability to independently evaluate complex situations to drive effective problem‑solving.  The Senior Quality Engineer is expected to demonstrate strong professionalism, communication skills, and the ability to manage multiple priorities in a fast‑paced environment.  A Certified Quality Engineer (CQE) credential or equivalent qualification is required.   The role demands reliability, a strong work ethic and a positive, collaborative approach while maintaining ownership of assigned responsibilities, projects and adapting to the evolving business needs.

Requirements

• Bachelor’s degree in engineering, science or related technical discipline.
• Minimum of 8 years of Quality experience in a GMP regulated environment.
• Minimum of 4 years of hands-on data analytics experience using Minitab within a GMP setting.
• Extensive working knowledge of cGMP, QMSR, ISO 13485 and ISO 14971 requirements.
• Certified Quality Engineer (CQE) credential or equivalent qualification required.
• High level of professionalism with excellent interpersonal and customer service skills.
• Exceptional time management abilities with proven success managing multiple priorities simultaneously.
• Outstanding verbal and written communication skills.
• Demonstrated ability to take ownership and drive tasks to completion.
• Demonstrated ability to work independently, collaborate effectively in a team, and drive projects to completion.
• Ability to work in a fast-paced environment with the flexibility to adjust to and adapt to shifting priorities.
• Strong analytical and problem-solving skills with sound decision making capabilities.
• Dependable, punctual and committed to maintain a positive attitude and strong work ethic.
• Must be authorized to work in the United States.

Responsibilities

• Lead the data analysis and continuous process verification program to ensure ongoing process control and product quality.
• Oversee the AI‑driven predictive analytics program to proactively identify trends, risks, and improvement opportunities.
• Manage the non‑conformance process, ensuring timely investigation, documentation, and resolution of quality issues.
• Direct the CAPA program, driving effective root‑cause analysis, corrective actions, and preventive measures.
• Administer and maintain compliance with external standards, including cGMP, QMSR, ISO 13485, and ISO 14971.
• Achieve established productivity and quality performance goals while supporting operational excellence.
• Adhere to all safety rules, quality standards, and company policies and procedures.
• Perform all assigned tasks in a safe, efficient and productive manner.
• Execute additional responsibilities, as assigned to support departmental and organizational objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level