Manufacturing QA Specialist (Medtech)

TL;DR

Manufacturing QA Specialist (Medtech): Supporting short-term manufacturing and quality-related operations with an accent on compliance, documentation, and technical oversight. Focus on managing deviations, change controls, batch reviews, and investigations to ensure adherence to regulatory standards.

Location: Must be based in the United States. While the role is remote, hybrid collaboration is encouraged for those near company offices.

Company

hirify.global provides expert consulting and operational support to biotech, med device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Manage and document deviations and investigations within manufacturing processes.
• Perform thorough batch reviews to ensure quality and compliance standards.
• Oversee change control processes and maintain laboratory protocols.
• Provide technical and quality oversight for manufacturing-related activities.
• Address manufacturing questions and ensure adherence to quality requirements.

Requirements

• Must be based in the United States.
• Proven experience in manufacturing quality assurance within the pharmaceutical or medtech industry.
• Strong understanding of quality systems, including change control and deviation management.
• Ability to work independently in a contract-based environment.
• Excellent communication skills for technical and quality oversight.

Culture & Benefits

• Commitment to diversity, equity, and inclusion in the workplace.
• Supportive environment that encourages innovative and entrepreneurial spirit.
• Personal review of all applications by the recruitment team.
• Transparent communication regarding application outcomes.