Job Title: Manufacturing Supervisor
Job Purpose: The candidate will work in a controlled cleanroom manufacturing environment, will lead a production team manufacturing medical catheters in conformance to established standards, and 13485 ISO regulations.
Essential Duties and Responsibilities include the following.
- Supervise a manufacturing team comprised of Group Leads and Assembly Technicians.
- Enforce compliance to Good Manufacturing Practices (GMPs), standard work and Standard Operating Procedure (SOPs).
- Assure the entire team is maintaining and executing required documents in a timely and accurate fashion.
- Develop action plans on both an individual and group level to increase performance of the team.
- Use problem solving methods and Lean manufacturing to identify, prioritize and execute continuous improvement activities that improve quality, safety and efficiency of work cells.
- Execute MedTrack transactions for serial number/lot control functions while creating top level packaging Device History Records (DHR’s)
- Review DHR’s to assure production team is following good documentation practices (GDP).
- Produce all required labels for catheters/accessories and all associated package labeling.
- Supervises the preparation and packaging of final assemblies for sterilization.
- Maintains an awareness of material locations and resources: Inventory, WIP, MRB, Awaiting Approval.
- Working with the Team leads plan all production work within the production assembly environment.
- Communicate daily and weekly plans and activities with the Director of Manufacturing.
- Use or maintain MRP, Accounting and/or production activity sheets (if required and trained)
- Participates and mentors team members in Lean continuous improvement activities.
Education and/or Experience – minimum two year degree from college or technical school; or 5+ years manufacturing related experience and/or training; or equivalent combination of education and experience.
Language Skills – Must have ability to read and understand SOP's and manufacturing procedures written in English. The candidate must speak English clearly and have the ability to understand spoken English.
Computer Skills - Basic, word processing, spreadsheet or database entry. Ability to learn operations or business software when properly trained.
While performing the duties of this Job, the employee is regularly required to stand, walk; sit; for extended periods of time.