Manager, Production

Ortho Clinical Diagnostics; Athens (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

QuidelOrtho in Athens, OH is seeking a Manager, Production to lead and develop a team of Production Supervisors in a fast-paced, regulated manufacturing environment. You will ensure safety, quality, and regulatory compliance across IVD and CE product lines, while optimizing schedules and resources to meet customer demand.

Responsibilities include budgeting, cost reduction initiatives, and driving continuous improvement.

Qualifications

• Bachelor's degree in life sciences, engineering or related field required or equivalent combination of education and experience with relevant certifications that may supplement educational requirements
• 6+ years of experience in manufacturing experience in regulated industries (medical device, pharmaceutical, or IVD) with 3+ years in a leadership role managing manufacturing teams or equivalent management experience
• SPC / Statistical knowledge and theory of risk management (preferred)
• Strong organizational skills to manage multiple priorities in a fast-paced environment
• Proactive and self-motivated with strong work ethic

Responsibilities

• Lead, mentor, and develop a team of Production Supervisors. Conduct performance evaluations and provide ongoing coaching and feedback.
• Foster a culture of collaboration, accountability, and continuous improvement. Manage team schedules, workload distribution, and resource allocation
• Ensure workplace safety by maintaining compliance with federal (OSHA), state, and local safety regulations across all manufacturing operations. Safeguard Regulatory & Quality departmental compliance with FDA IVD regulations (21 CFR 820), EU MDR 2017/746 for CE marking, ISO 13485, and all applicable product registration requirements
• Oversee daily manufacturing operations for IVD and CE product lines, ensuring compliance with quality, regulatory, and safety standards. Collaborate with Supply Chain and Production Supervisors to develop optimized production schedules
• Monitor annual production budgets ensuring alignment with organizational financial goals. Identify and implement cost-saving initiatives through process optimization and waste elimination

Skills

Leadership

Data-driven decisions

Organizational skills

Detail-oriented

Proactive

Results-oriented

Education

Bachelor's degree in life sciences, engineering or related field

Job description

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Manager, Production. This role is responsible for ensuring efficient, compliant, and high-quality manufacturing processes while leading a team of production staff to meet business objectives. This role will be located onsite in Athens, Ohio.

Responsibilities

• Team Management - Lead, mentor, and develop a team of Production Supervisors. Conduct performance evaluations and provide ongoing coaching and feedback. Foster a culture of collaboration, accountability, and continuous improvement. Manage team schedules, workload distribution, and resource allocation
• Safety & Compliance - Ensure workplace safety by maintaining compliance with federal (OSHA), state, and local safety regulations across all manufacturing operations. Safeguard Regulatory & Quality departmental compliance with FDA IVD regulations (21 CFR 820), EU MDR 2017/746 for CE marking, ISO 13485, and all applicable product registration requirements
• Production Planning, Operation & Monitoring - Oversee daily manufacturing operations for IVD and CE product lines, ensuring compliance with quality, regulatory, and safety standards. Collaborate with Supply Chain and Production Supervisors to develop optimized production schedules that meet customer demands and delivery deadlines. Ensure adequate availability of materials, equipment, and personnel through effective resource and capacity planning. Track and analyze production KPIs (OEE, yield, throughput, on-time delivery) and drive continuous improvement initiatives to enhance operational performance
• Budget & Cost Management - Monitor annual production budgets ensuring alignment with organizational financial goals. Identify and implement cost-saving initiatives through process optimization and waste elimination. Lead continuous improvement projects focused on reducing costs per unit while maintaining product quality. Improve labor utilization and productivity metrics to reduce operational expenses. Optimize stocking levels of raw material, WIP and finished goods inventory
• Perform other duties & projects as assigned

Individual Required

• Bachelor's degree in life sciences, engineering or related field required or Equivalent combination of education and experience may be considered with relevant certifications that may supplement educational requirements
• 6+ years of experience in manufacturing experience in regulated industries (medical device, pharmaceutical, or IVD) with 3+ years in a leadership role managing manufacturing teams or equivalent management experience
• SPC / Statistical knowledge and theory of risk management (preferred)
• Strong organizational skills to manage multiple priorities in a fast-paced environment
• Sound judgment and ability to make data-driven decisions under pressure
• Detail-oriented with commitment to quality and compliance
• Proactive and self-motivated with strong work ethic
• Results-oriented with strong accountability
• This position is not currently eligible for visa sponsorship
• Preferred: Plastics Processing Fundamentals, Polymer Material Selection & Handling, Tooling & Fixtures Design Validation & Process Controls

Key Working Relationships

• Internal Customers: Biochemist, Production, Biochemist, Quality, Director Operations, Production Supervisors and Production Managers
• External Customers: Quality Operations, Supply, Engineers & Equipment Technicians

The Work Environment

Manufacturing/production environment (30%) with office-based responsibilities (70%). May require occasional evening or weekend work to support system changes or urgent documentation needs. Some travel may be required

The Physical Demands

Sitting and/or standing for extended periods (6-8 hours per day). Lift Up to 25 lbs. occasionally. Fine motor skills: Writing, typing, operating small equipment. Repetitive motions: Typing, mouse clicking. View computer screen for prolonged periods. Read standard text on computer screens and printed materials. Distinguish colors for coding systems and safety signage. Perceive depth and spatial relationships for office navigation. Maintain focus for extended periods on detailed work. Speaking clearly on phone and in person. Hearing and understanding conversations. Participating in meetings and presentations. Responding to questions and requests.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties.