Technical Line Lead Medical Devices

Location: Vandalia OH (Onsite)
Facility: Medical Devices Operations
Department: Production / Operations
Vacancy Type: Existing Position

As our next Technical Production Line Lead Medical Devices you will lead and support manufacturing operations within an assigned production area dedicated to the assembly of FDAregulated wearable medical devices. This role combines handson technical production work with floor leadership ensuring products are manufactured efficiently accurately and in full compliance with FDA regulations ISO 13485 and internal quality system requirements.

• Recognition Programs: Programs that recognize and reward employee achievements and contributions.
• Community Engagement: Opportunities to participate in community service and corporate social responsibility initiatives.
• Strong Leadership: Work under experienced and visionary leaders who guide the company towards success.
• Innovation Hubs: Access to state-of-the-art facilities and innovation hubs that foster creativity and development.

• 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 ontime delivery targets
• Identifying documenting and escalating quality issues nonconformances 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 handson line work to maintain production flow troubleshoot issues and meet production commitments

• 23 years of experience working in medical device manufacturing
• 23 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
• Ability to understand follow and train others on technical assembly processes and quality standards
• Proven ability to lead by example and support a compliant qualityfocused culture
• Strong problemsolving and analytical skills
• Comfort working in regulated environments with GMP and GDP requirements

• 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

• Climatecontrolled medical device manufacturing environment
• Strict adherence to cleanliness safety GMP and regulatory standards
• Handson production floor role

Apply online at We cant wait to meet you!