Quality Manager

Job Description

Job Description

The Quality Manager will execute a comprehensive quality system, manage a growing quality team, and ensure compliance across all product categories. This role is highly hands-on and essential to maintaining regulatory readiness, with expected growth ahead.

Key Responsibilities:

• Build and oversee a quality team, including staffing, training, and ongoing development.
• Execute, and continue to develop, implement, and update SOPs across manufacturing, testing, and documentation workflows for medical devices, OTC products, and cosmetics.
• Maintain and renew key certifications and regulatory requirements (cGMP, FDA registration, ISO 13485, OTC monograph compliance, cosmetic GMP).
• Lead audit preparation, on-site audits, and follow-up activities.
• Design and execute document control processes, including electronic batch records, deviations, CAPAs, and change management.
• Oversee product quality systems: incoming inspection, in-process checks, finished goods release, stability studies, and complaint handling.
• Partner with production, R&D, and commercial teams to embed quality throughout the product lifecycle.
• Track and improve quality metrics such as defect rates, audit findings, and out-of-specification events.
• Ensure all activities align with FDA, industry standards, and applicable international regulations.

Qualifications

• 5+ years of quality assurance or quality management experience in contract manufacturing, ideally with exposure to medical devices, OTC products, or cosmetics.
• Experience building quality systems and teams, especially in a scale-up or startup environment.
• Strong knowledge of regulatory standards including 21 CFR Part 210/211, cGMP, and cosmetic regulations.
• Hands-on experience writing SOPs, implementing QMS processes, and managing document control.
• Excellent project management and multitasking capabilities.
• Effective communicator able to train teams and interact confidently with auditors.
• Bachelor's degree in a relevant scientific or engineering discipline preferred; ASQ certifications are a plus.
• Detail-oriented, proactive, and adaptable in a dynamic environment.

This role offers a competitive salary, with a great compensation package, and strong opportunities for growth.

InSpec Solutions, LLC is a market leading contract manufacture of topical OTC and Cosmetic Products. We are experience rapid growth and can offer boundless opportunities for growth.

Company Description

InSpec Solutions, LLC is a market leading contract manufacture of topical OTC and Cosmetic Products. We are experience rapid growth and can offer boundless opportunities for growth.