Production Supervisor

The Production Supervisor oversees daily manufacturing operations within the cleanroom / controlled environment, ensuring that CENTERPIECE’s medical devices are produced safely, efficiently, and in compliance with regulatory standards such as FDA, ISO 13485, and GMP. This role is responsible for supervising production personnel, maintaining quality standards, and meeting and reporting production targets while fostering a culture of continuous improvement and safety.**Essential Duties and Responsibilities**:1. Production Oversight & Efficiency- Supervise daily production activities to meet output, quality, and schedule requirements.- Ensure adherence to manufacturing procedures, work instructions, and batch records (DHR’s).- Monitor production metrics (Efficiency, Adh to Plan, Downtime, Scrap) and implement corrective actions as needed.- Coordinate with maintenance, quality, and planning teams to minimize disruptions.2. Compliance & Documentation- Ensure operations comply with FDA regulations, ISO 13485, GMP, and internal quality standards.- Review and approve production records, logs, and deviations.- Support internal and external audits by maintaining accurate documentation and traceability.- Lead root cause investigations and assist in CAPA implementation for non-conformances.3. Team Leadership & Development- Lead, coach, and motivate production staff to achieve performance and safety goals.- Conduct regular team meetings, safety briefings, and performance evaluations.- Identify training needs and coordinate cross-training to build team flexibility.- Address personnel issues and enforce disciplinary procedures as needed.4. Safety & Cleanroom Protocols- Promote a safety-first culture and ensure compliance with EH&S policies.- Ensure all employees are trained on gowning, hygiene, and cleanroom behavior.- Enforce proper use of PPE and adherence to environmental controls.- Participate in safety audits, risk assessments, and incident investigations.5. Continuous Improvement & Lean Practices- Drive process improvements using lean manufacturing and 5S principles.- Promote and participate in kaizen events and suggest innovations to enhance efficiency and reduce waste.- Monitor and report key performance indicators (KPIs) and drive improvement initiatives.- Support implementation of new products, equipment, and processes through validation and training.**Academic Background**:- Bachelor’s degree in industrial or manufacturing engineering, Business Administration or related careers, or equivalent work experience.Work Experience:- Minimum 3-5 years of supervisory experience in a regulated manufacturing environment, preferably medical devices or pharmaceuticals.- Solid knowledge of FDA, ISO 13485, GMP, and cleanroom operations.- Proficient in manufacturing systems (ERP/MES), MS Office, and production reporting tools.- Solid knowledge in RCA, CAPAs and continuous improvement processes.Technical Skills:- Proficiency in continuous improvement tools such as Lean, Six Sigma, and root cause analysis.- Experience in the creation and analysis of production reports, key metrics (KPIs), and trend analysis.- Fair knowledge of statistical process control (SPC) and process validation methodologies.Soft Skills:- Leadership and management of multidisciplinary teams.- Exceptional verbal and written communication skills.- Strategic decision making and complex problem-solving skills.Languages:- Moderate English, both written and spoken (essential).Tipo de puesto: Tiempo completo, Por tiempo indeterminadoSueldo: $900.00 - $1,500.00 al díaBeneficios:- Descuento de gimnasio- Descuentos y precios preferenciales- Estacionamiento gratuito- Seguro de gastos médicos- Seguro de gastos médicos mayores- Vales de despensaTipo de jornada:- Turno de 12 horasExperiência:- Previous experience supervising production teams: 3 años (Obligatorio)- Strong knowledge of production, quality, and safety KPIs: 3 años (Obligatorio)- Experience in medical or regulated manufacturing: 3 años (Obligatorio)Idioma:- Inglés (Obligatorio)Lugar de trabajo: Empleo presencialFecha de inicio prevista: 23/06/2025