Sterilization Control Assurer (12 Months fixed term)
$69 500 - $110 900 por añoJornada completa
Stryker
What you will do
As a Sterilization Control Assurer , you will be responsible for ensuring that sterilization processes are properly validated, maintained, and compliant with all applicable regulatory and quality standards. You will oversee sterilization cycles, monitor environmental controlled areas, and support product adoption activities while guaranteeing product sterility. Additionally, you will work closely with cross-functional teams to evaluate processes, review documentation, investigate non-conformances, and ensure that all products released meet strict regulatory requirements.
Main Responsibilities
• Ensure compliance with sterilization control regulatory requirements for the production and release of sterile products
• Maintain full adherence to quality systems and applicable standards (e.g., QSR, ISO)
• Review and maintain documentation and procedures according to current regulatory requirements
• Monitor sterilization control systems and environmental controlled areas (ECA)
• Support batch record review and final product release processes
• Track and analyze performance metrics, trends, and audit results to identify improvement opportunities
• Evaluate changes impacting sterilization processes to ensure compliance
• Conduct investigations of non-conformances and deviations
• Recommend and implement corrective and preventive actions (CAPA)
• Support audits and ensure continuous process compliance
What you need
Required:
- Bachelor’s degree in Science or related field (Biology or Microbiology preferred)
- 3–5 years of experience in Quality or Compliance within an FDA-regulated environment
- Strong knowledge of medical device regulations and standards (QSR, ISO 13485, ISO 11135, ISO 11137, ISO 14644, ISO 10993)
- Hands-on experience with sterilization validation, cycle monitoring, and cleanroom and/or EO/Gamma sterilization technologies
- Solid background in microbiology, sterility testing, and non-conformance investigations (including root cause analysis and CAPA)
- Proven experience in documentation control, batch record review, and product release within a quality system
- Experience with audits, process monitoring, trending, and continuous improvement initiatives
Preferred:
- Certifications or training in Sterilization, Lean Six Sigma, Lead Auditing, Risk Management, or Train-the-Trainer; experience acting as SME in sterilization or microbiology
United States of America Pay Ranges:
- USN : $69,500 - $110,900 USD Annual
- Puerto Rico : $69,500 - $110,900 USD Annual
- US5 : $73,000 - $116,400 USD Annual
- US10 : $76,500 - $122,000 USD Annual
- US15 : $79,900 - $127,500 USD Annual
- US20 : $83,400 - $133,100 USD Annual
- US30 : $90,400 - $144,200 USD Annual
Vacante publicada el 4 días atrás
Empleos similares que podrían interesarleBasado en la vacante Sterilization Control Assurer (12 Months fixed term) en Arroyo
$69 500 - $110 900 por año
...internal and external audits; deliver training sessions on quality assurance procedures and regulatory requirements. Design and implement inspection and testing methods, including statistical process control, to maintain product precision and reliability. Stop...SugeridoTemporalTiempo completoContrato$64 400 - $94 400 por año
...Conduct internal and external audits and provide training on quality assurance topics. Design and implement inspection, testing, and... ...Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services...SugeridoTemporalContrato- ...For Sterilization/Validation services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Science... ...and implements. Develops, validates, and implements controlled environment methods. Applies existing techniques and procedures...SugeridoContratoTrabajo por turnos
$17,28 - $25,23 por hora
...HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help...SugeridoSalario mínimoTemporalTiempo completo$80 000 - $100 000 por año
...Coordinate sample builds, trials, and testing. Support change control processes, validation, and implementation (e.g., cut-in planning... ..., as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance...SugeridoTemporalVisa de trabajo- ...during construction. Responsibilities Oversee quality control activities for civil, electrical, and electromechanical works.... ...or transmission lines). Availability to work on-site for 6–8 months. Valid TN Visa is mandatory. English is not mandatory....ContratistaTiempo completo
- ...developing, reviewing, and maintaining controlled documents that support compliance, traceability... ...tools. Partner with Quality Assurance, Manufacturing, Engineering, and Digital... ...knowledge of GMP/GxP requirements, document control practices, and data integrity principles...Contrato
- ...collection Maintain cleanliness and safety of work areas Follow infection control, HIPAA, and VA policies Assist with specimen processing and lab support tasks Qualifications Minimum 6 months phlebotomy experience Experience in a healthcare or clinical setting...Tiempo completo
$16 - $18 por hora
...and weekend hours. Preferred Qualifications Prefer six months of experience in a retail environment. Prefer to have prior... ...good computer skills. Prefer the knowledge of store inventory control. Prefer PTCB certification. We will consider employment...Trabajo de temporadaInicio inmediatoTrabajo por turnos- ...Germany, Canada, and South America. Essential Functions: Assure compliance with client site Environmental and Waste Management... ...test, and operate equipment and devices used in the prevention, control, and remediation of environmental problems, including waste treatment...Tiempo completoCAS
- ...through various roles within the area, including, in some cases, a control room rotation. Driving and operating agricultural machinery... ...experience Location: Aibonito, P.R. (for the first 3 months and then continue on Salinas, P.R.) Have reliable transportation...Trabajo de veranoPrácticaTemporalTrabajo por turnosFin de semana
- ...Empleo part-time • Horario diurno • Ambiente de trabajo estable • Pago: $***** por hora ?? Horario: Lunes a domingo | 7:00 AM – 12:00 PM ?? Interesados llamar o escribir: ************ O el Email: ****** Requisitos: ? Requisitos: • Con o sin experiencia...Por horaTiempo parcialEmpleo permanenteTurno de mañana
- ...la solicitud. Requisitos: • Área de Cidra • Cuarto año completado • Experiencia en manejo de montacargas y producción • Licencia de conducir vigente de PR • Disponibles para trabajar turnos de 12 horas diurnos y nocturnos Enviar resume a: ****** / ******...Turno de nocheTrabajo por turnos12 horas
- ...of significant complexity. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and/or validation departments. Work under the direct supervision of project managers to complete design, engineering, and construction...ContratistaContratoVisa de trabajoTrabajo por turnos
- ...línea de producción Acomodo de mercancía Procesos de documentación Entre otras. Interesados pueden compartir su resumé a ****** Requisitos: Requisitos: Disponibilidad para turnos de 12 horas AM O PM Interesados pueden compartir su resumé a ******...Trabajo por turnos12 horas
- ...comunicarse al ********** Requisitos: - Licencia de conducir vigente de Puerto Rico. - Disponibilidad completa para turnos rotativos de 12 horas. - Diploma de Escuela Superior. - Experiencia en el manejo de montacargas Forklift. - Conocimiento básico en el uso de...Turno rotativo12 horas
$22,5 - $31 por hora
...pharmacy operations. Coordinates and organizes pharmacy daily schedule of activities. Recommends allocation of pharmacy hours. Assures the pharmacy is clean, neat, orderly, and stocked with adequate supplies. Under the direction of the pharmacist, exercises independent...Por horaTiempo completoTurno de tarde- ...that may impact the project(s) adversely, and communicating these on a timely manner. ~ All documentation must be free of errors, controlled and well-organized. ~ Manage technical issues/problems appropriately and efficiently. ~ Guarantee top quality of services...ContratistaTiempo completoContratoCAS
- ...investigation, or quality system documentation. Root cause investigation methodologies (5 Whys, Fishbone, Fault Tree Analysis) Risk Management (ISO 14971) FDA, ISO 13485, MDSAP, and EU MDR regulations Quality Management Systems (QMS) and document control practices...Contrato
- ...procedures within the company security policy. MINIMUM REQUIREMENTS High school diploma or equivalent required; or one to three months related experience and/or training; or equivalent combination of education and experience. Must be able to obtain and maintain all...Trabajar en la oficinaTrabajo por turnos
$2 000
...profesionalmente y aumentar tus ingresos basado en tu desempeño, esta es tu oportunidad. Compensación: $1,400.00 - $2,000.00 per month Somos un empleador con igualdad de oportunidades y todos los candidatos calificados recibirán consideración por el empleo...Tiempo completoTurno de nocheHorario flexibleTrabajo por turnosFin de semana- ...maintenance, or project support, preferably in FDA-regulated or life sciences environments. Strong knowledge of electrical systems, controls, PLCs, and instrumentation. Understanding of GMP, FDA regulations, and quality systems is a plus. Proficiency in English;...Tiempo completo
- ...class manufacturing industry in Puerto Rico & USA. Responsibilities: Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that products are free of flaws and function as designed. Designs and...TemporalTrabajo por turnosFin de semana
- ...persona seleccionada colaborará con el Gerente de la Tienda en la supervisión del personal, el cumplimiento de metas de ventas, el control de inventario y la excelencia en la atención al cliente. Interesados(as) favor de enviar su resumé ****** Requisitos: Cuarto año...Inicio inmediatoTurno de nocheTrabajo por turnos
- ...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell...Tiempo completo
- ...quality standards. Preventive Maintenance Execute planned preventive maintenance tasks on production equipment, utilities, and control systems. Follow established procedures, maintenance schedules, and equipment manuals. Identify and report equipment...Tiempo completo
- ...para trabajar turnos rotativos * Experiencia en manejo de alimentos (Food Safety) * Método FIFO * Registro de temperaturas * Control de vida útil de alimentos * Experiencia recibiendo, acomodando y registrando compras/inventario * Experiencia en supervisión y...Por horaTiempo completoTurno rotativoTrabajo por turnos
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a Sterilization Control Assurer (12 Months fixed term). ¡Sea el primero en aplicar!
