Production Team Lead - Medical Devices
Johnson Electric · Vandalia, OH · 1 mo ago
ManufacturingFull-time
About the role
Join Our Team as a Technical Line Lead – Medical Devices at Johnson Electric! Location: Vandalia, OH (Onsite) Facility: Medical Devices Operations Department: Production / Operations Vacancy Type: Existing Position
Responsibilities
- Performing and overseeing assembly of wearable medical devices in accordance with approved work instructions, Device Master Records (DMRs), and quality system procedures
- Assigning production operators to tasks, balancing workloads, and coordinating quick changeovers while maintaining quality and traceability
- Training and coaching production operators on manufacturing processes, equipment use, quality requirements, and Standard Operating Procedures (SOPs)
- Ensuring compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485 requirements, and internal quality policies
- Verifying adherence to Good Documentation Practices (GDP), including accurate and timely completion of production records
- Enforcing safety standards, lean manufacturing principles, and 5S workplace organization
- Monitoring production performance to maximize efficiency, minimize waste, and support on-time delivery targets
- Identifying, documenting, and escalating quality issues, non-conformances, equipment concerns, and resource needs to the Supervisor
- Supporting corrective and preventive actions (CAPA), root cause analysis, and continuous improvement initiatives
- Participating in and recommending GK (continuous improvement) activities to enhance quality, efficiency, and compliance
- Actively performing hands-on line work to maintain production flow, troubleshoot issues, and meet production commitments
Requirements
- 2–3 years of experience working in medical device manufacturing
- 2–3 years of experience in a Line Lead or leadership role
- Minimum 1 year of experience working in compliance with FDA regulations
- Strong attention to detail and commitment to quality and documentation accuracy
- Strong problem-solving and analytical skills
- Comfort working in regulated environments with GMP and GDP requirements
Qualifications
- Technical capability and process understanding
- Strong attention to detail and thoroughness
- Proven ability to lead by example and support a compliant, quality-focused culture
- Regulatory and quality compliance awareness
Skills
- Leadership and team support
- Technical capability and process understanding
- Attention to detail and thoroughness
- Problem-solving and root cause analysis
- Regulatory and quality compliance awareness
Benefits
- Recognition Programs
- Community Engagement
- Strong Leadership
- Innovation Hubs
Pay
Negotiable based on experience and qualifications.
Schedule
Full-time position with flexible hours to accommodate production needs.
Contact
To apply, please visit www.johnsonelectric.com — We can't wait to meet you!