Manufacturing Lead - Mira Mesa - Medical Device

Manufacturing Lead
- Mira Mesa
- Medical Device - $29.15/hr Job Description

The Manufacturing Lead oversees daily production activities to ensure weekly manufacturing goals and yields are consistently achieved in a regulated environment. This is a hands-on leadership role that combines operating manufacturing equipment with monitoring performance, compliance, and documentation standards. The Manufacturing Lead guides a production team in following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and related standard operating procedures (SOPs), while supporting staffing, training, and process improvement initiatives to minimize rejects and field complaints.

• Lead a production team in achieving weekly manufacturing goals and targeted yields while maintaining high quality standards.

• Act as a working lead by operating manufacturing equipment and participating directly in production activities.

• Monitor team performance to ensure strict adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and all related SOPs.

• Ensure the team consistently follows good documentation practices, including accurate, timely, and compliant recordkeeping.

• Track production goals and respond proactively to spikes or unscheduled increases in demand to prevent back orders.

• Support staffing needs by assisting with scheduling, staff rotation, and break planning to maintain adequate coverage across the shift.

• Coordinate smooth shift transfers by communicating production status, issues, and priorities to incoming teams.

• Lead department training activities, including onboarding and cross-training, and maintain compliant and up-to-date training records.

• Assist in evaluating and piloting new manufacturing technologies and processes to minimize issues during initial and subsequent production runs.

• Maintain accurate production, quality, and training records in accordance with GDP and applicable SOPs.

• Track and implement corrective action protocols to address production, quality, and process issues.

• Work cross-functionally with other departments to coordinate corrective actions for technical problems related to raw materials and finished products.

• Identify and help implement process improvements to reduce rejects, minimize field complaints, and increase manufacturing efficiency.

• Oversee and support activities related to assembly, packaging, machine operation, and other manufacturing processes as needed.

• Promote a culture of safety, quality, and continuous improvement within the manufacturing team.

• Three (3) to five (5) years of manufacturing experience in a regulated medical device manufacturing or pharmaceutical environment.

• Previous lead experience in a manufacturing environment, with experience leading a team of approximately 20 people preferred.

• Hands-on experience with manufacturing processes, including assembly, packaging, and machine operation.

• Demonstrated ability to supervise production activities and guide a team to meet production goals.

• Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).

• Familiarity with FDA regulations and quality processes in a regulated manufacturing environment.

• Ability to maintain accurate and compliant records in alignment with GDP and SOP requirements.

• Proven skills in production management, including staffing support, scheduling, and shift coordination.

• Experience working in cleanroom or controlled manufacturing environments.

• Ability to identify issues and implement corrective actions to address production and quality problems.

• Effective communication and interpersonal skills to lead, train, and coordinate with cross-functional teams.

• Strong organizational and time management skills to balance hands-on production work with leadership responsibilities.

• Experience in medical device assembly or pharmaceutical production.

• Background in process improvement within a manufacturing environment.

• Working knowledge of Microsoft Office applications.

• Experience using a large Enterprise Resource Planning (ERP) system.

• Familiarity with quality processes and systems used in regulated manufacturing.

• Ability to support and lead department training initiatives and maintain training documentation.

• Comfort working with new technologies and participating in pilot runs or process validations.

The organization offers a clear path to…