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Quality Engineer

Insight Global

Newark, NYJobNo compensation foundTracked 3w agoSeen in employer's feed 4 days ago

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At a glance

Compensation
No compensation found
Location
Newark, NY
Work Authorization
Not specified

Job overview

Insight Global is hiring a Quality Engineer. Insight Global seeks a Quality Engineer/Quality Systems consultant to support a CPG customer transitioning to regulated OTC product packaging, establishing compliant processes, developing documentation, and ensuring FDA OTC packaging and labeling compliance on‑site.

Key focus areas include Assess and remediate quality system gaps identified during client audits., Develop and implement OTC‑compliant quality procedures and processes., and Partner with the site’s quality team to establish sustainable quality practices..

Important skills include Develop Quality Documentation, Hands-On Implementation Support, Remediate Quality System Gaps, Develop OTC-Compliant Quality Procedures, Implement OTC-Compliant Quality Procedures, and Establish Sustainable Quality Practices.

Skills & qualifications

RequiredNice to have

Skills

Develop Quality DocumentationHands-on Implementation SupportRemediate Quality System GapsDevelop OTC-Compliant Quality ProceduresImplement OTC-Compliant Quality ProceduresEstablish Sustainable Quality PracticesSupport Operational ReadinessWrite SOPsRevise SOPsImplement SOPsWrite Work InstructionsRevise Work InstructionsImplement Work InstructionsEnsure Compliance With FDA OTC Packaging and Labeling RequirementsChange ControlCAPADeviation SystemsTraining Systems

Qualifications

Experience Working With OTC ProductsExperience Writing SOPs, Procedures and Work Instructions for OTC Products5-7+ Years Quality Engineering Experience

Full job description

Job Description

Insight Global is looking for a Quality Engineer/Quality Systems consultant to support a CPG customer that is transitioning from consumer product packaging to regulated OTC product packaging. The consultant will work on-site to help establish compliant OTC packaging processes, develop quality documentation, and provide hands-on implementation support.

  • Assess and remediate quality system gaps identified during client audits.

  • Develop and implement OTC-compliant quality procedures and processes.

  • Partner with the site's quality team to establish sustainable quality practices.

  • Support operational readiness for OTC product packaging.

Write, revise, and implement SOPs, work instructions, and quality documentation.

  • Ensure compliance with applicable FDA OTC packaging and labeling requirements.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

- Experience working with OTC products

- Experience writing SOPs, procedures and work instructions for OTC products

- 5-7+ years of Quality Engineering, Quality Systems, or Quality Assurance experience

- Change control, CAPA, deviation and training systems exp

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