Production Manager

Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. 

Ingersoll Rand is a Fortune 500 company with a passion for making lives better.  We do this by living our values, and through a relentless focus on the success of our customers and partnering with our employees to think and act like owners. We believe in sustainability through the development and distribution of a broad range of global brands designed to meet the needs of our customers in both efficient and responsible ways. Ingersoll Rand is a diverse and inclusive environment.  For more information visit: www.irco.com.

Position Objective:

We are seeking an experienced Production Manager to lead and optimize our manufacturing operations in an FDA 21 CFR 820 compliant environment, with a strong emphasis on quality and regulatory adherence. This role will focus on driving operational efficiency, ensuring compliance with FDA regulations, and overseeing production processes that meet the highest quality standards. The ideal candidate will have expertise in production management, process optimization, and maintaining compliance with regulatory standards in a dynamic, fast-paced environment.

Responsibilities:

• Oversee and manage daily production activities to ensure operational efficiency, meeting production targets and minimizing downtime.
• Ensure strict compliance with FDA 21 CFR 820 regulations, including design controls, production, and process controls, CAPA processes, and product traceability.
• Drive continuous improvement initiatives by identifying areas for operational optimization and implementing lean manufacturing practices.
• Collaborate closely with cross-functional teams (Quality, Engineering, Supply Chain, etc.) to resolve production issues, maintain product quality, and enhance operational performance.
• Develop, implement, and update Standard Operating Procedures (SOPs) and work instructions to ensure regulatory compliance and best practices in production.
• Lead and mentor the production team to improve skills, productivity, and engagement while ensuring adherence to quality and regulatory standards.
• Ensure that all production activities are conducted in compliance with ISO 9001:2015 and ISO 13485:2016 standards.
• Prepare and present regular reports on production performance, quality metrics, and any regulatory compliance issues to senior management.
• Monitor and enforce workplace safety practices, ensuring the safe handling and proper storage of materials in accordance with FDA regulations.
• Lead the preparation for internal and external audits, ensuring readiness for FDA inspections and ISO certifications.

Requirements:

• Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or a related field (or equivalent experience).
• Minimum of 5 years of experience in a production management role within an FDA 21 CFR 820 regulated environment, preferably in medical devices or pharmaceuticals.
• Strong knowledge and hands-on experience with 21 CFR 820 regulations, including quality management, production controls, and CAPA processes.
• Experience in managing production teams, optimizing workflows, and improving operational efficiency while ensuring regulatory compliance.
• Familiarity with ISO 9001:2015 and ISO 13485:2016 quality systems standards, with a focus on compliance in manufacturing operations.
• Proven ability to lead continuous improvement initiatives and implement lean manufacturing practices.
• Strong communication, leadership, and problem-solving skills, with the ability to work collaboratively across departments.
• Proficiency in MS Office, ERP systems, and quality management systems (QMS).
• Knowledge of FDA inspection processes and preparation for regulatory audits.
• Lean or Six Sigma certifications are a plus.

Ingersoll Rand Inc. (NYSE:IR), driven by an entrepreneurial spirit and ownership mindset, is dedicated to helping make life better for our employees, customers and communities. Customers lean on us for our technology-driven excellence in mission-critical flow creation and industrial solutions across 40+ respected brands where our products and services excel in the most complex and harsh conditions. Our employees develop customers for life through their daily commitment to expertise, productivity and efficiency. For more information, visit www.IRCO.com.