Job Description

Job Description

Job Description

Job Title: Quality Assurance Manager

Location: Boerne, TX

Job Type: Full-time

Schedule : Monday-Thursday

About Us: Aegis Worldwide is a recruiting firm that works with clients in the manufacturing and engineering space. Our client is a leading provider of high-quality pharmaceutical products committed to improving global health. With a dedication to innovation, integrity, and excellence, we strive to exceed industry standards in all aspects of our operations.

Job Description:

We are seeking a highly skilled and experienced Quality Assurance Manager to join the team. The Quality Assurance Manager will play a crucial role in ensuring that our products meet regulatory requirements and exceed customer expectations for quality and safety. The ideal candidate will have a strong background in quality management, experience in FDA-regulated environments, and a proven track record of driving continuous improvement initiatives.

Responsibilities:

• Collaborate with clients/customers to address and resolve quality issues, ensuring timely and effective resolution.
• Lead internal audits in accordance with ISO 9001 standards, ensuring compliance with regulatory requirements and internal policies.
• Conduct root cause analysis and implement corrective actions to prevent recurrence of quality issues.
• Utilize a Quality Management System (QMS) to document, track, and report quality metrics and performance indicators.
• Develop and implement quality assurance procedures and best practices to optimize processes and enhance product quality.
• Provide leadership and guidance to cross-functional teams to drive a culture of quality and continuous improvement.
• Stay current with industry trends, regulatory changes, and best practices in quality management.

Qualifications:

• Bachelor's degree in a related field (e.g., Quality Management, Chemistry, Pharmacy, Engineering, etc.).
• Minimum of 2 years of experience in a quality manager or similar role in an FDA-regulated environment, preferably in the pharmaceutical industry.
• Strong knowledge of quality management principles, ISO standards, and FDA regulations.
• Experience conducting internal audits and leading corrective and preventive action (CAPA) processes.
• Excellent communication, interpersonal, and problem-solving skills.
• Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
• Strong leadership skills with the ability to motivate and influence cross-functional teams.

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