Manufacturing Packaging Filling and Assembly Team Lead

Quantimetrix; Redondo Beach (CA); Vor Ort; USD 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Medical, Dental and Vision options

Employer Paid Life Insurance and AD&D

Voluntary Life and Disability (GI)

Training resources and Certification

Adoptions Assistance

FSA and HSA

Employee discounts

Cell phone discounts

EAP and nurse line

Telemedicine options

Zusammenfassung

Quantimetrix in Redondo Beach, CA is seeking a Packaging/Filling/Assembly Team Lead to coordinate daily production activities in the packaging, filling, and assembly areas, ensuring GMP/ISO 13485 compliance and traceability through DMRs and documentation.

You will lead operators, monitor performance, provide training, and drive continuous improvement while fostering a culture of safety, accountability, and teamwork within the department.

Qualifikationen

• 1–2 years of GMP manufacturing experience in medical device, diagnostics, or life sciences.
• No licenses or certifications needed.

Aufgaben

• Coordinate and oversee daily packaging, filling, and assembly activities to meet production schedules and quality standards.
• Ensure compliance with GMP, ISO 13485, safety requirements and company procedures.
• Maintain and verify batch records, logbooks, and DMR documentation in real time.
• Review batch documentation for accuracy before QA submission.
• Verify correct components, materials, and labels per work order and DMR specs.
• Conduct in-process quality checks (label verification, lot checks, torque, visual).
• Identify deviations or safety issues and escalate to management/QA.
• Support internal audits for GMP, SOPs, and documentation control.
• Provide direction, assignments, and feedback to operators.
• Mentor team members and develop technical skills for leadership roles.
• Promote safety and organized work environment; enforce housekeeping standards.
• Participate in process improvements to reduce waste and enhance lean practices.
• Collaborate with QA/management on CAPA, NCMR, NCR as needed.
• Monitor equipment setup and changeovers to minimize downtime.
• Support ERP data accuracy for material usage, lot traceability, and production entries.

Kenntnisse

GMP manufacturing

Leadership experience

Packaging operations

Filling operations

Assembly operations

IQMS ERP

DocumentationAccuracy

CAPA/Deviation knowledge

Tools

IQMS ERP

Jobbeschreibung

The Packaging/Filling/Assembly Team Lead is responsible for coordinating and overseeing daily production activities within the packaging, filling, and assembly areas to ensure efficient, compliant, and high-quality manufacturing operations. This position plays a key role in maintaining adherence to GMP standards, Device Master Records (DMRs), and all associated documentation to ensure traceability and compliance with regulatory and internal quality requirements. The Team Lead acts as the main point of contact between production staff, quality assurance, and management, ensuring alignment of schedules, resources, and expectations. This individual provides day-to-day directions to operators, monitors performance, verifies documentation accuracy, and ensures production activities are executed according to approved DMRs and work instructions. In addition to daily operations, the Team Lead plays an active role in training and developing employees to build a capable and self-sufficient workforce. This includes mentoring staff, and fostering a culture of accountability, continuous improvement, and safety awareness throughout the department.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Coordinate and oversee daily packaging, filling, and assembly activities to meet production schedules and quality standards.
• Ensure all work is performed in compliance with GMP, ISO 13485, safety requirements, and company procedures.
• Maintain strict adherence to Device Master Records (DMRs), ensuring all documentation, batch records, and logbooks are completed accurately, legibly, and in real time.
• Review completed batch documentation for accuracy and completeness prior to submission to QA.
• Verify correct components, materials, and labels are issued and used per work order, BOM, and DMR specifications.
• Conduct and document in-process quality checks (e.g., label verification, lot number checks, torque inspection, and visual inspection).
• Identify, document, and elevate any deviations, nonconformances, or safety issues to management and QA in a timely manner.
• Support and conduct internal audits to ensure compliance with GMP, SOPs, and documentation control requirements.
• Provide clear direction, task assignments, and performance feedback to production operators to ensure effective daily execution.
• Support and mentor team members to develop technical skills and readiness for future leadership or team lead roles.
• Promote a safe and organized work environment through consistent enforcement of safety and housekeeping standards.
• Participate in process improvement initiatives to enhance efficiency, reduce waste, and support lean manufacturing practices.
• Collaborate with QA and management to implement corrective and preventive actions (CAPA), NCMR, NCR as needed.
• Monitor equipment setup and changeovers to minimize downtime and optimize workflow efficiency.
• Support ERP system accuracy by ensuring proper reporting of material usage, lot traceability, and production entries (IQMS experience preferred).
• Perform other tasks and duties as directed by management and supervisory personnel.
• Foster a positive team culture centered on accountability, quality, and operational excellence

EDUCATION/LICENSES/CERTIFICATIONS

• Minimum 1–2 years of GMP manufacturing experience, preferably in medical device, diagnostics, or life sciences
• No licenses or certifications needed.

KNOWLEDGE, SKILLS AND ABILITIES

• Minimum 1–2 years of GMP manufacturing experience, preferably in medical device, diagnostics, or life sciences.
• Strong working knowledge of packaging, filling, or assembly operations within a regulated environment.
• Prior leadership or team lead experience is strongly preferred.
• Proficiency in ERP systems (IQMS experience a plus).
• Excellent attention to detail with strong documentation and communication skills.
• Demonstrated ability to train, coach, and develop team members.
• Knowledge of deviation reporting, root cause analysis, and CAPA processes is preferred

COMPANY OVERVIEW

Quantimetrix, located in Redondo Beach, California, is a family-owned company that designs, develops, and manufactures clinical laboratory quality controls. For nearly 50 years, we have delivered industry-leading products and services to the medical community.

BENEFITS

• Medical, Dental and Vision options
• Employer Paid Life Insurance and AD&D
• Additional Voluntary Life insurance and Disability (Guaranteed issue for the 30 days)
• Free Training resources and Certification programs
• Adoptions Assistance
• FSA and HSA
• Market place for large company discounts (Travel, auto, shopping, entertainment and various services)
• Cell Phone discounts (Verizon and AT&T)
• Employee Assistance program and nurse line 24/7
• Telemedicine options with insurance plans