Production Supervisor

Erbe Medical, LLC; Tempe (AZ); On-site; USD 70,000 - 100,000; Full time

Job summary

Erbe Medical, LLC is seeking an experienced Production Supervisor to oversee daily manufacturing operations in a medical device environment. You will lead a production team, ensure schedules are met, and guarantee compliance with FDA, ISO, and GMP standards.

The role requires 7+ years in lead operator roles, ERP/MRP experience, and strong leadership with a focus on quality and safety. Occasional overtime and a fast-paced, regulated setting are expected.

Qualifications

• Lead Operator experience in manufacturing or equivalent.
• Experience with MRP/ERP systems and MS Office.
• Knowledge of FDA, ISO 13485, GMP quality systems.
• Strong leadership and team mentoring abilities.
• Ability to read and follow work instructions and procedures.
• Experience in a clean room environment.
• Excellent problem-solving and decision-making skills.
• Detail-oriented with strong organizational skills.
• Effective communication and multitasking in fast-paced setting.

Responsibilities

• Oversee daily production activities in a medical device manufacturing environment and manage production staff.
• Coordinate workflow and ensure schedules are met efficiently and on time.
• Ensure processes follow work instructions, regulatory requirements, and quality standards (FDA, ISO).
• Monitor production performance, yields, and address deviations.
• Lead, train, and mentor a team to maintain performance, safety, and morale.
• Ensure staff are trained on equipment, processes, safety, and quality requirements.
• Conduct regular evaluations and provide feedback for improvement.
• Foster continuous improvement and compliance with policies.
• Ensure adherence to quality control through inspections and final reviews.
• Collaborate with Quality Assurance to investigate non-conformances and corrective actions.
• Maintain records of production data, inspections, and incidents.
• Enforce safety procedures and safe working environment.
• Stay up to date with FDA, ISO 13485, and GMP compliance.
• Investigate safety hazards and report resolutions.
• Ensure timely availability of materials and coordinate with supply chain to prevent delays.
• Oversee documentation of material usage and waste reduction.
• Identify opportunities for process improvements and lean manufacturing.
• Collaborate with engineering to implement new processes and technologies.
• Follow SOPs and safety guidelines; perform other duties as needed.

Skills

Leadership

MRP/ERP

Clean room

Regulated industry

Documentation reading

5S/TPM

Inventory management

Decision making

Organizational skills

Communication

Multitasking

ERP software

Education

High School Diploma or equivalent

Tools

Microsoft Office

ERP systems

Job description

Essential Responsibilities

To oversee daily production activities in a medical device manufacturing environment, ensuring the efficient and safe production of high-quality medical devices. This role involves managing production staff, coordinating workflow, and ensuring compliance with industry standards, regulations, and company policies. The ideal candidate will have experience in medical device manufacturing, strong leadership skills, and the ability to work in a fast-paced, regulated environment.

• Operate, inspect, and troubleshoot production line machinery and/or assemblies.
• Supervise and lead the day-to-day operation of the production line, ensuring production schedules are met efficiently and on time.
• Ensure the production process follows established work instructions, regulatory requirements, and quality standards (FDA, ISO, etc.).
• Monitor production performance, track production yields, and address any deviations from standard procedures.
• Lead, train, and mentor a team of production workers to maintain a high level of performance, safety, and morale.
• Ensure all staff are trained on equipment, processes, safety protocols, and quality requirements.
• Conduct regular performance evaluations and provide feedback for improvement.
• Foster a culture of continuous improvement and ensure employee compliance with company policies and procedures.
• Ensure adherence to quality control standards by monitoring in-process inspections and final product reviews.
• Work closely with the Quality Assurance department to investigate non-conformances, identify root causes, and implement corrective actions.
• Maintain accurate records of production data, quality inspections, and any incidents that may impact product quality or safety.
• Enforce all safety procedures and ensure a safe working environment for the production team.
• Stay up to date with relevant regulations, including FDA, ISO 13485, and GMP (Good Manufacturing Practices), and ensure the team complies with these standards.
• Investigate and report any safety hazards or incidents to the appropriate departments and work on resolutions.
• Ensure timely availability of materials and components required for production.
• Coordinate with the materials and supply chain departments to monitor stock levels and prevent delays due to material shortages.
• Oversee proper documentation of material usage and assist in managing waste reduction.
• Identify opportunities for process improvements in efficiency, quality, and cost-effectiveness.
• Collaborate with engineering and operations teams to implement new manufacturing processes or technologies.
• Contribute to the development and implementation of lean manufacturing principles.
• Follow and enforce all established safety, health, quality GMPs and all applicable SOPs.
• Performs other duties as assigned based on business needs.

Supervisory Responsibility

This position has direct supervisory responsibility.

Work Environment

This position operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and stoop; use hands to finger, handle or feel; and reach with hands and arms. The employee frequently is required to lift and/or carry up to 20 pounds. For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Thursday, 5:00 a.m. to 4:00 p.m. Occasional evening and weekend work may be required as job duties demand.

Travel

This position requires no measurable travel.

Required Education and Experience

• High School Diploma or equivalency

• 7+ years of Lead Operator experience in manufacturing or equivalent experience
• Working knowledge of Microsoft Office applications
• 6+ MRP/ERP experience

• 6+ years of clean room experience
• Medical device industry or regulated industry experience

• Experience following work instructions, process documentation, and procedures to ensure safe working conditions
• A team-driven attitude to work together and support department initiatives such as 5S and Total Productive Maintenance Systems (TPM)
• The ability to complete production paperwork which includes inventory accurately

• Excellent decision-making and problem-solving skills
• Strong organizational skills

Position Requirements

• Must be dependable, reliable and have a good work ethic
• Detail oriented – quality and precision focused
• Ability to remain flexible and open to change within a fluid global industry
• Strong communication skills to interact with team members, supervisors, and other departments
• Ability to manage multiple tasks in a fast-paced environment

• Proficiency with manufacturing software (e.g., ERP) and the ability to read and interpret technical documents

Competencies

• Problem Solving/Analysis
• Results Driven
• Detail Orientation
• Customer Focus
• Technical Capacity
• Communication Proficiency

Additional Eligibility Qualifications

None required for this position.

Work Authorization/Security Clearance

Employees must be legally authorized to work in the United States. Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.

AAP/EEO Statement

Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.

Other Duties

Please note this position description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.