Production Supervisor

100 - Operations · Aliso Viejo, California
Department 100 - Operations
Employment Type Full-Time
Minimum Experience Mid-level

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Production Supervisor responsible for the overall execution of Production strategy, including finished assemblies of electro-mechanical devices and surgical sets.  This role supervises the Production and Shipping/Receiving Teams, setting daily goals, and regularly updating and reporting KPIs.  This role has full responsibility for maintaining OrthAlign’s Visual Factory, removing roadblocks to meeting all goals.  This position interacts with Operations, Engineering, and Quality teams working collaboratively to deliver products that fulfill OrthAlign’s SIOP process, Quality Management System, and Good Manufacturing Practices per FDA and International Regulatory Standards.
 

You will:

  • Work with Production to eliminate constraints and roadblocks
  • Coordinate with Supply Chain to allocate resources for Production based on demand, workload, and customer priorities
  • Evaluate product assembly to company standards, looking for streamlining opportunities
  • Maintain safe and clean working environment by complying with procedures, rules, and regulations
  • Work with written specifications and manufacturing instructions to assemble a variety of medical devices
  • Have full responsibility for our Safety Program ensuring safe work practices, proper training, and continued vigilance in our program
  • Maintain WO information on Daily Production Report
  • Support audits and inspections as SME (Subject Matter Expert) on production and QC procedures, documents, and records
  • Lead daily meetings with Production and QC teams to establish priorities and discuss constraints

 

You need:

  • 5 years' experience in a Supervisory role in medical device manufacturing
  • Knowledge of ISO 13485 and 21 CFR Part 820 requirements
  • Experience using calipers, micrometers, height gauges, gage blocks, microscopes and similar inspection tools
  • Attention to detail
  • Good written and verbals communication skills
  • Sound judgement when making decisions and communicating information
  • Ability to read and interpret engineering drawings, ANSI-Y14.5 dimensioning and tolerancing
  • Experience with ERP/MRP software, preferably Expandable, and understanding material transactions
  • Ability to initiate and manage time effectively with little supervision

 

We offer:

  • Innovative products
  • Awesome benefits
  • Great coworkers
  • An evolving, engaging culture and workspace

 

It is an exciting time at OrthAlign - make your next career move with us!

Thank You

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  • Location
    Aliso Viejo, California
  • Department
    100 - Operations
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level