The Processing Supervisor is responsible for directing all activities related to Processing (in his/her respective business unit) for transplant in a controlled and regulated medical device environment. This position requires the Supervisor to work closely with Management and Team Leaders in assigning processing resources to meet production demands in an ISO (International Organization for Standardization) certified cleanroom. This position requires the Supervisor to work cross functionally with; peers, engineering, planning, quality, and supply chain to ensure efficient management of value streams, resources and quality control. The Supervisor will oversee daily operational activities through key performance indicators including; safety, quality, processing and compliance. The Supervisor will actively manage both inside and outside the core processing areas and ensure adherence to the Standard Operating Procedures (SOP’s), corporate Policy and MTF Quality Standards. The Supervisor participates in process improvement initiatives to remove waste and improve overall efficiencies in the Value Stream. In addition, the Supervisor will assist with new tissue commercialization and validations to support. The Supervisor may also play an active role in regards to compliance in terms of; NCR’s and complaint management. Finally the Supervisor will work closely with the training team to develop employee competencies needed for flexibility, responsiveness and employee growth.
Develops team members and promotes teamwork, collaboration and continuous improvement. This is done through one-on-ones, team meetings and by spending time in the cleanroom and controlled environments working with team members.
Actively manages his/her team in the controlled environments including the cleanroom as well as outside the controlled environment.
Meets with employees on a routine basis. Promotes job enrichment and goal obtainment.
Performs observations to ensure adherence to procedure and policy. Maintains safety standards and ensures that safe and quality tissue is processed. Monitors and supports organization of the cleanroom environment.
Interviews, hires and assists with new employee development and training. Conducts team meetings to keep the processing team well informed of current goals and any relative information and to promote a teamwork environment.
Attends Business Unit meetings related to Product Line Management, Sales and Operations Planning, New Tissue Commercialization and Project Meetings.
Supports Processing Associate Manager/Manager and BU Leader on their respective shifts to see that commercialization activity and business directives are executed consistently across all shifts.
Balances production requirements with capacity and monitors capacity in relation to current and future demand.
Oversee department’s metrics such as Production, Inventory, Goals, Quality, Safety, and Errors.
Performs annual evaluations of direct reports and completes merit and bonus activities.
Adheres to the Progressive Discipline Policy while enforcing Processing departmental guidelines.
Maintains direct reports payroll and PTO approvals.
May work on or assist with non-conformances and addresses processing related complaints. Creates and implements corrective action plans where appropriate. Works with the Trainer to ensure the processing technicians are informed and trained in regards to processing related NCR’s, complaints, and errors. Works with the Training department to ensure team members are competent.
Works closely with support departments such as Human Resources, Facilities, Planning, Marketing, Process Engineering, Supply Chain, Quality Assurance, Quality Control, Document Control, Regulatory, Chemical Operations, and Quality Engineering.
Works with R&D, Marketing and Engineering on process improvements, line extensions, and new product development and validation support.
Maintains working knowledge of the processes he/she is responsible for. Works with a wide range of equipment and chemicals such as cutting tools, measuring tools, Spor- klenz, bleach, and Ethanol in an ISO controlled environment.
Required to work weekends and/or off hours when necessary to meet organizational needs. This includes preparation for both bi-annual and weekend shutdowns of cleanrooms and works closely with the Facilities department to make appropriate preparations.
May provide back-up support in the absence of another Supervisor or Team Leader.
May perform process activities in times of need.
Assists with special projects and performs additional duties as assigned.
High School Diploma
2 years experience in one of the following: tissue banking, supervision, surgical technician, nursing or related medical technology background, medical device or pharmaceutical manufacturing or production type environments, ISO class 8 or less clean room / controlled environment.
Specific Licenses and/or Certifications:
Specialized Knowledge, Skill, and Abilities*:
1. Strong interpersonal skills coupled with strong leadership abilities.
2. Must have the ability to work cross functionally in a compliant structure while fostering a collaborative and continuous learning environment.
Ability to work in a closed Clean room and or office environment for extended hours, manufacturing, or health care related.
1. Able to lift 40lbs.
2. Must wear sterile clean room attire and PPE and work standing up in this attire for extended periods.
3. Works with potential biological hazardous waste and materials.
1. College Coursework in; science, business or relevant field.
2. College degree – Business, Science or relevant field.
1. Tissue Banking,
2. Medical Device Manufacturing.
Specific Licenses and/or Certifications:
Training in; Six Sigma, lean manufacturing.
Specialized Knowledge, Skill, and Abilities:
1. Current Good Manufacturing Practices (cGMP’s – FDA Code of Regulations 21 CFR Part 210 & 211),
2. Quality System Regulations (QSR’s – FDA Code of Federal Regulations 21 CFR Part 820).
3. Current Good Tissue Practices (cGTP’s – FDA Code of Federal Regulations - 21 CFR Part 1271).
4. Basic computer skills,
5. ability to work independently and in a team environment,
6. organizational ability,
7. Stand for long periods of time.
8. Work environment - ISO 14644-1 Classification 4 – 8, Federal Standard 209E - Class 10 – 100,000
Equal Employment Employer – Vet/Disability