Quality Systems Manager

American Nitrile's mission is to bring quality manufacturing back to the United States through our state-of-the-art nitrile glove facility, located in Grove City. We are thrilled to be recruiting great folks to join our team and we will strive to provide a culture that is fun, engaging, and offers an amazing challenge! We will strive to be the Best Workplace in Ohio!

We offer a place to be yourself where the position you hold is critical for every life-saving glove we produce!

As the Quality Systems Manager at American Nitrile, you will play a pivotal role in ensuring the highest standards of quality and regulatory compliance across all aspects of our manufacturing processes. You will oversee ISO audits, ensure document control is accurate and complete, and implement effective quality management systems to uphold our reputation for excellence in the nitrile glove industry.

Responsibilities:

• Lead and manage the Quality Assurance team to ensure adherence to quality standards and regulatory requirements.

• Develop and implement quality management systems to drive continuous improvement and optimize manufacturing processes.

• Ensure all documents are controlled per the company standard.

• Create and implement SOPs (Standard Operating Procedures).

• Ensure QMS (Quality Management System) is accurate and up to date per the company's Quality Manual.

• Conduct regular ISO audits to maintain compliance with ISO 13485 standards and other relevant regulatory frameworks.

• Collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs teams to ensure alignment on quality objectives and initiatives.

• Provide leadership and guidance in resolving quality-related issues and implementing corrective and preventive actions.

• Drive initiatives to enhance product quality, reliability, and customer satisfaction through data-driven analysis and process optimization.

• Serve as a subject matter expert on quality assurance principles, best practices, and industry standards.

• Foster a culture of quality and accountability throughout the organization through training, coaching, and mentorship initiatives.

Qualifications:

• Minimum of 5 years' experience in a Quality Management role.

• Experience in a quality management role within the medical manufacturing industry highly preferred.

• Proven track record of leading successful ISO audits and maintaining compliance with ISO 13485 standards.

• Strong understanding of quality management systems, regulatory requirements, and industry best practices in medical device manufacturing.

• Demonstrated leadership experience with the ability to motivate and inspire cross-functional teams towards achieving quality objectives.

• Extensive experience in Document Control.

• Excellent communication, interpersonal, and problem-solving skills.

• Detail-oriented mindset with a passion for driving continuous improvement and delivering superior quality outcomes.

• Relevant certifications such as Certified Quality Manager (CQM) or Certified Quality Auditor (CQA) are a plus.