What are the responsibilities and job description for the Production Manager position at Bionix®?
Summary of Position
The Production Manager is responsible for ownership and execution of production operations in a regulated medical device manufacturing environment. This role is hands-on and floor-focused, with accountability for production output, employee performance, and adherence to quality system requirements.
The Production Manager leads and develops production personnel, establishes control of daily operations, and ensures production processes are executed consistently and efficiently. This role is responsible for maintaining alignment between documented procedures and actual practices, driving standardization of work, and ensuring production schedules are met while minimizing backorders and operational disruptions.
The Production Manager is expected to take initiative and act independently to address issues, enforce standards, and maintain a high level of accountability within the production environment.
Essential Duties and Responsibilities
- Own daily production execution, ensuring output, schedule adherence, quality requirements, and labor utilization are consistently met
- Establish and maintain control of production operations through active floor presence, clear direction, and proactive management of workflow and priorities
- Lead, manage, and develop production personnel through regular one-on-one communication, performance feedback, and ongoing coaching
- Address performance, attendance, and behavioral issues promptly and directly, including documentation and coordination with Human Resources as required
- Assign and adjust work based on production priorities, employee capability, and training status to ensure effective utilization of labor
- Monitor production performance and respond to gaps in output, efficiency, or quality, taking corrective action to resolve issues and prevent recurrence
- Enforce adherence to approved procedures, quality system requirements, and safety policies, ensuring all work is performed and documented accurately
- Ensure alignment between documented procedures and actual practices by identifying gaps, correcting deviations, and reinforcing expectations
- Define, implement, and maintain standardized work (One Best Way) for key production processes to ensure consistency, efficiency, and quality
- Ensure employees are properly trained and qualified for assigned tasks and that training records are accurate and current
- Coordinate with Engineering, Purchasing, Quality, and Operations leadership to ensure production readiness, including availability of materials, documentation, equipment, and staffing
- Identify constraints, inefficiencies, and recurring issues within production and take action to resolve or escalate as needed
- Support corrective and preventive actions (CAPAs), investigations, and implementation of process improvements
- Maintain a clean, organized, and compliant production environment in accordance with established standards
- Communicate production performance, risks, and issues to Operations and Quality leadership in a timely and accurate manner
- Perform additional operational and administrative duties necessary to support production operations
Supervisory Responsibilities
- Directly supervise production employees through consistent on-floor presence, active engagement, and clear day-to-day leadership
- Establish and maintain clear expectations for performance, behavior, attendance, and adherence to procedures, and ensure those expectations are consistently applied across all employees
- Hold employees accountable through timely, direct feedback, coaching, and appropriate corrective actions in coordination with Human Resources
- Make informed recommendations regarding hiring, promotion, discipline, and termination, and support execution of those decisions
- Ensure effective onboarding and training of new employees, and reinforce ongoing development of existing staff
- Foster a culture of accountability, consistency, and compliance within the production department
Authorities for Position
- Make day-to-day operational decisions within the production area to ensure safe, compliant, and efficient execution of work
- Assign, reassign, and prioritize work based on production needs, employee capability, and operational priorities
- Enforce production, quality, and safety standards and require adherence to approved procedures and documentation practices
- Stop production or halt specific activities when quality, safety, or compliance concerns are identified
- Initiate and document performance coaching and corrective actions, and coordinate with Human Resources on disciplinary actions in accordance with company policy
- Require retraining, reassignment, or removal of employees from tasks when competency or compliance expectations are not met
- Take action to address operational, personnel, or quality issues impacting production performance or compliance, and escalate when appropriate
Competency Required for Position
- Demonstrated ability to lead and manage employees in a manufacturing environment, including providing direct feedback, addressing performance issues, and holding individuals accountable to expectations
- Proven ability to take ownership of production operations and act independently to resolve issues, make decisions, and maintain control of the work environment
- Working knowledge of quality system requirements and controlled documentation practices, with the ability to operate effectively within a regulated manufacturing environment
- Demonstrated ability to interpret, apply, and enforce work instructions and procedures, and to ensure alignment between documented processes and actual practices
- Demonstrated willingness to address issues directly and in a timely manner, rather than allowing problems to persist or escalate
- Ability to identify process breakdowns, inefficiencies, and nonconformances, and take appropriate corrective action to resolve issues and prevent recurrence
- Experience establishing and maintaining standardized work to drive consistency, efficiency, and quality in production processes
- Ability to manage multiple priorities and respond effectively to changing production needs while maintaining attention to detail and operational control
- Strong communication skills, with the ability to provide clear direction, set expectations, and ensure understanding across the production team
- Ability to remain objective, consistent, and professional when addressing performance, quality, or compliance issues
Qualifications Required for Position
- High School Diploma or equivalent required; Associate’s or Bachelor’s degree in a related field preferred
- Minimum of 5 years of experience in a manufacturing environment, with progressive responsibility and at least 2 years in a direct supervisory or leadership role
- Demonstrated experience managing production personnel, including addressing performance issues, enforcing expectations, and maintaining accountability
- Experience working in a regulated or structured manufacturing environment (e.g., ISO-certified, medical device, pharmaceutical, food, or similar) preferred
- Working knowledge of standard operating procedures, controlled documentation, and production processes
- Proficiency with basic computer applications, including ERP systems and Microsoft Office (Word, Excel, Outlook)
- Strong written and verbal communication skills
- Ability to work on-site in a production environment with frequent standing, walking, and interaction with production personnel