Lead Operator

## Lead Operator Apply locations:
US - Maple Plaintime type:
Full time posted on:
Posted Todayjob requisition :
R91244

Job Advert
** Life Unlimited.
** At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Lead Operator is a hands-on production lead who safely operates and supports manufacturing/assembly processes while coordinating day-to-day workflow for operators. This role prioritizes patient safety and product quality, ensures compliance with applicable quality system requirements (e.g., GMP/cGMP, SOPs, work instructions), and helps the team meet schedule, quality, and productivity targets through strong communication, problem-solving, and continuous improvement.##
***** This position is not offering any type of visa transfer or sponsorship now or in the future
******* What will you be doing?**##

Key Responsibilities
* ** Safety & compliance:
** Promote a safe, clean, and compliant work environment; follow EHS requirements and escalate hazards, incidents, and near-misses.
* ** Quality first:
** Execute work per SOPs/routers/work instructions; perform in-process and final inspections; identify, segregate, and communicate nonconforming material.
* ** Lead daily execution:
** Help set shift priorities; coordinate staffing and job assignments; remove blockers to maintain flow and meet schedule.
* ** Hands-on production:
** Perform assembly/build/packaging operations high attention to detail and documentation accuracy.
* ** Material flow & schedule adherence:
** Prioritize and manage work orders on the floor to improve lead time and mix attainment; coordinate materials, tools, gauges, and line clearances/closures as required.
* ** Equipment set-up & troubleshooting:
** Set up, operate, and monitor equipment/fixtures; respond to faults and perform basic troubleshooting; escalate issues to Engineering/Maintenance/Quality.
* ** Shift communication:
** Provide clear status updates and shift-to-shift handoff communication on safety, quality, output, and open issues.
* ** Training & coaching:
** Serve as a resource to operators; help onboard/train/cross-train team members; identify training gaps and support qualification activities.
* ** Continuous improvement:
** Identify and implement opportunities to prevent issues, improve yields, reduce waste, and improve process capability (Lean/5S, standard work, fast changeover).
* ** Audits & documentation:
** Complete production records, batch/device history documentation, and manufacturing reports; support process audits and investigations as assigned.
* ** Cross-functional coordination:
** Collaborate with Production, Quality, Engineering, Planning, and Supply Chain to troubleshoot issues and maintain production flow.
* ** Housekeeping:
** Maintain 5S and cleanroom/controlled-area requirements (where applicable), including cleaning and organization of work areas.
** Other duties:
** Perform administrative tasks and special projects as assigned; support policy/procedure compliance and maintain positive working relationships.
** What will you need to be successful?
**** Minimum Qualifications
**** Education**:
High school diploma or equivalent.
** Experience**:
* 2+ years of manufacturing, assembly, or production experience (regulated manufacturing such as medical device preferred). Food or other regulated.
* Demonstrated ability to coordinate work, communicate clearly, and make day-to-day safety/quality/production decisions.
** Knowledge:
*** Ability to read and follow work instructions, strong attention to detail and documentation accuracy.
* Comfortable using basic computer systems (e.g., Microsoft Office; ERP such as SAP is a plus).
** Competences:
*** Ability to work flexible hours/days, overtime, and shift rotation as business needs require.
* Overtime may be expected.
** Preferred Qualifications
***
* Experience:

*** Prior experience leading or training others (lead operator, team lead, trainer, etc.).
* Medical device experience; familiarity with FDA QSR/ISO 13485 and GMP/cGMP expectations.
* Experience with Lean Manufacturing, 5S, standard work, and continuous improvement tools.
** Knowledge:
*** Ability to interpret basic prints/specifications and use common…