Assistant Lead

VALTO Inc, a fast-growing medical device company transforming treatment for uterine fibroids, is seeking an Assistant Lead for our Day Shift operations. In this on-site role, you'll coordinate daily production of the VALTO System, supporting a cross-functional team to meet output, quality, and safety goals in a regulated environment. You'll guide operators, monitor workflows, complete in-process checks, and maintain accurate GMP/ISO 13485 documentation.

Partner with engineering and quality on continuous improvement, new product builds, and process refinements that directly impact women's health outcomes worldwide.

Responsibilities

• Support day-to-day coordination of day shift production activities for VALTO's medical device line
• Monitor workflow, assign tasks, and adjust priorities to meet quality, safety, and throughput targets
• Assist with training, coaching, and guiding shift associates on SOPs, GMP, and device handling
• Perform in-process checks, basic troubleshooting, and escalate issues to engineering or quality teams
• Document production data accurately in electronic and paper records to meet regulatory requirements
• Collaborate with quality, engineering, and supply chain on process improvements and root-cause analysis
• Ensure adherence to safety, cleanliness, and 5
• S standards within the production area
• Support execution of validation builds, pilot runs, and new product introductions on the line
• Communicate shift status, issues, and results in handoff meetings and daily standups
• Champion a culture of continuous improvement and patient-focused, high-quality production

Required Skills

• GMP manufacturing
• ISO 13485 documentation practices
• Medical device assembly and handling
• In-process quality inspection
• Basic equipment troubleshooting
• Production scheduling and prioritization
• Root cause analysis and CAPA support
• Electronic batch record/data entry
• Lean/5
• S production methods
• Training and coaching of operators