Duties and Responsibilities (Key Deliverables):
Overall responsibility for the 1st ,2nd and 3rd shifts for packaging, cleaning and labeling operations for implant and sterile/non-sterile instruments to include daily and weekly capacity planning to ensure production goals and quality objectives are met.
Collaborate with the Material Handling team to ensure all materials required for ongoing packaging activities are identified and available on time and take any actions necessary based on inventory discrepancies or safety stock levels.
Develop, communicate, implement, measure and meet or exceed daily, monthly and annual goals and objectives utilizing effective shift change communication status updates, Key Performance Indicators and Packaging X-matrix as monthly communication methods to the team
Communicate any gap closing actions to leadership to ensure objectives are met
Understand and ensure Quality system policies, procedures, documentation, packaging validation and training methodologies are applied in all Production operations
Participate in global compliance audits to include follow up activities such as Corrective and Preventive Actions
Develop and implement accurate packaging standards and identify quality, work flow efficiency improvements to include prevention activities to preclude potential product mix ups and quality defects.
Integrate the demand planning and work order generation and WIP flow based on current capacity and monthly volume targets
Predict future packaging volume using the monthly long-term demand and capacity model and resource requirements based on demand plan
Ensure all QAD transactions required for the Packaging process are accurate, complete and updated as required to include new product introductions and packaging rework activities.
Oversee packaging and weekly activities utilizing equipment and resource capacity to meet production schedules.
Develop and maintain clean and safe working conditions to prevent accidents and ensure product integrity
Understand and comply with all department safety policies and procedures
Understand and participate and/or lead packaging and labeling process functional effort for all corrective and preventive action activities.
Recommend and directs personnel activities of department such as recruiting, hiring, performance evaluation, and salary adjustments.
Actively participates in team meetings or on multi-skilled teams as necessary.
Prepare, recommend and effectively manage the annual Packaging expense, headcount and capital budget.
Develop and implement a formal written departmental communication plan.
Practice leadership as stated in the Exactech Leadership Model
Ensure organizational alignment in the design and execution of initiative efforts
Establishes clearly defined individual goals
Responsible for hiring and terminations within the department as required
Provide leadership to include effective feedback on culture, results and future, coaching and mentoring, performance management and career development
Assure compliance to the code of ethics
Assist and support other employees, team and sales personnel as necessary.
Develop a continuous improvement culture and implement improvement activities driven via Gemba walks and long-term strategy.
Bachelor's Degree from an accredited institution required or equivalent industry experience.
Minimum of 5 years' experience in the processing or manufacturing of medical device products is preferred
Excellent understanding of medical device quality management system requirements
Prior team management and leadership experience
Prior knowledge and experience in ERP and MRP applications as applied to customer supply chain or logistics activities and initiatives
Functional/Technical Knowledge, Skills and Abilities Required:
Good organizational, documentation, communication and computer skills
Ability to balance process control with process outputs, along with problem solving and root cause analysis skills
Ability to establish collaborative working relationships with cross- functional teams
Proven track record of being a change agent
Practitioner of lean manufacturing principles