Overview
Senior Quality Engineer Jobs in Newark, NY at Intellectt Inc
Title: Senior Quality Engineer
Company: Intellectt Inc
Location: Newark, NY
Senior Quality Engineer (Quality Systems – OTC Products)
Location: Newark, NY (Onsite)
Job Summary
We are seeking a Senior Quality Engineer with strong OTC (Over-the-Counter) product experience to support a manufacturing site transitioning from consumer product packaging to FDA-regulated OTC product packaging. This role focuses on developing and implementing compliant quality systems, documentation, and processes.
Responsibilities
- Assess and remediate quality system gaps identified during audits.
- Develop and implement FDA-compliant quality procedures and processes.
- Write and revise SOPs, work instructions, and quality documentation.
- Support Change Control, CAPA, Deviations, and Training systems.
- Partner with the site quality team to establish sustainable quality practices.
- Support operational readiness for OTC product packaging.
- Ensure compliance with FDA OTC packaging and labeling requirements.
Required Qualifications
- 5–7+ years of experience in Quality Engineering, Quality Systems, or Quality Assurance.
- Hands-on experience with OTC products is required.
- Experience writing SOPs, procedures, and work instructions for OTC products.
- Strong experience with Change Control, CAPA, Deviations, and Training systems.
- Experience working in FDA-regulated and GMP manufacturing environments.
- Excellent documentation, compliance, and quality systems experience.
Note: Only candidates with direct OTC product experience will be considered.
