Quality Control Lead Inspector
Medical Device | Pharmaceutical | Biotech Manufacturing
?? On-Site Position
?? Direct Hire Opportunity
?? $28.00 - $30.00 per Hour
?? Full-Time
Lead Quality Excellence in a Regulated Manufacturing Environment
Are you a hands-on quality professional who thrives on the manufacturing floor and in cleanroom environments? We are seeking a Quality Control Lead Inspector to join a growing regulated manufacturing operation supporting the medical device, pharmaceutical, and biotech industries.
This is a direct hire opportunity offering long-term career growth, stability, and the chance to make an immediate impact on product quality, compliance, and operational excellence. You'll serve as a key quality resource, working closely with production, engineering, and leadership teams to ensure products are manufactured to the highest standards.
What You'll Be Doing
Quality Oversight & Cleanroom Support
- Provide a strong quality presence on the manufacturing floor and within controlled cleanroom environments.
- Support daily production activities by ensuring adherence to GMPs, approved procedures, documentation requirements, and quality standards.
- Conduct routine floor audits, process observations, line clearances, and cleanroom inspections.
- Monitor contamination control practices, environmental monitoring activities, and compliance with gowning requirements.
- Escalate quality concerns and support immediate containment when required.
Inspection & Documentation
- Perform incoming, in-process, and final inspections using approved specifications, drawings, sampling plans, and measuring equipment.
- Review production records, batch documentation, inspection reports, and quality documentation for accuracy and compliance.
- Support product status decisions including hold, quarantine, segregation, and release readiness activities.
- Maintain accurate documentation and product traceability.
Investigations & Nonconformance Management
- Initiate and support nonconformance, deviation, and quality event activities.
- Assist with investigations, root cause analysis, and corrective action efforts.
- Support product corrections and rework activities while ensuring compliance with approved procedures.
- Coordinate containment activities and help prevent unintended use or release of affected material.
Team Leadership & Continuous Improvement
- Provide daily guidance to quality inspectors and production personnel.
- Coach employees on GMP compliance, good documentation practices, contamination control, and quality expectations.
- Participate in production meetings, shift handoffs, risk assessments, and continuous improvement initiatives.
- Prepare quality summaries, reports, and key metrics for leadership.
Qualifications
Required
- 4+ years of experience in Quality Control, Quality Assurance, Quality Operations, Manufacturing Quality, Inspection, or Engineering.
- Experience in a regulated manufacturing environment such as:
- Medical Devices
- Pharmaceuticals
- Biotechnology
- Life Sciences Manufacturing
- Knowledge of cGMPs, FDA quality system requirements, and ISO 13485 and/or ISO 9001 standards.
- Experience supporting cleanrooms, contamination control programs, and environmental monitoring activities.
- Strong understanding of nonconformances, deviations, investigations, product traceability, and documentation requirements.
- Ability to effectively communicate and collaborate across production, engineering, and quality teams.
Preferred
- Associate's or Bachelor's degree in Quality, Engineering, Life Sciences, Manufacturing, or a related technical field.
- Experience with ERP systems and electronic Quality Management Systems (QMS).
- Familiarity with Syteline, QT9, or similar software platforms.
- Experience supporting product rework, correction activities, and controlled material processes.
Work Environment
This is a highly visible, floor-focused leadership role. The ideal candidate is someone who enjoys being actively engaged in manufacturing operations rather than working primarily from an office.
- Spend the majority of the workday on the production floor and in cleanroom environments.
- Wear required PPE and cleanroom gowning.
- Stand and walk for extended periods.
- Support multiple operational areas as business needs require.
Why Apply?
? Direct Hire Position
? Stable, Growing Industry
? Opportunity to Lead Quality Initiatives
? Collaborative Team Environment
? Career Growth Potential
? Competitive Pay: $28.00 - $30.00 per Hour
If you're passionate about quality, compliance, and continuous improvement in a regulated manufacturing environment, we'd love to hear from you. Apply today!
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.