Quality Systems Compliance Auditor

Descripción y detalle de las actividadesJob Description Summary:This position is responsible for conducting internal quality system/compliance audits according to FDA, ISO/EN and other international regulations. Responsible for coordinating, managing, and directing the quality system internal audit teams; evaluates the quality and process controls of Merit’s Quality Systems.ESSENTIAL FUNCTIONS PERFORMED1. Performs regulatory and system internal audits to ensure systems are documented, procedures are followed and are adequate.2. Accomplishes compliance work requirements by training, mentoring, assigning, and guiding internal auditors.3. Prepares audit plans and identifies the roles and responsibilities of audit team members.4. Observe, examine and report compliance and conformance by assessing systems, processes and products against documents related to the requirements making up the audit criteria.5. Conducts audit process meetings.6. Prepares audit reports by collecting, analyzing, and summarizing operating information and trends and report audit results.7. Follows up on audit results and reports status of corrective actions.8. Assists in finding solutions to enable operational functions to comply with requirements.9. Meets with department heads and various personnel to discuss compliance issues.10. Maintains records demonstrating specified requirements have been met, including corrective and preventative actions.11. Performs other related duties and projects as required.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS- Lifting - Not to exceed 50 lbs. - local practice may apply.- Writing- Sitting- Standing- Bending- Vision- Color perception- Depth perception- Reading- Field of vision/peripheral- Fine motor skillsExperiência y requisitos- Education and/or experience equivalent to a Bachelor's Degree and five years of quality system compliance auditing and/or regulatory experience.- CAPA's experience (must) (CAPA owner experience would be a plus)- Working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, CMDCAS, JGMPs and other medical device related standards.- Excellent interpersonal and oral/written communication skills. Proficient English required.- Strong organizational skills, the ability to be self-motivated and detailed oriented.- Must be a team player, have the ability to work well with others and meet deadlines in a timely manner.- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.- Knowledge of basic quality principles and the ability to utilize these methods in a manufacturing environment.- Must be able to manage project schedules and timelines in a cross-functional environment.- Excellent organizational skills and the ability to work under strict time constraints.- Strong analytical skills and attention to detail.COMPETENCIES- Regulatory compliance policy and procedure- Regulatory compliance corrective action plan/audit- Procedure research and evaluation- Compliance evaluation/communication- Audit results reporting- Special projects/assignments- Continuous improvement- Information preparation/analyze/summarize management communication- Computer skillsCOMMENTS- Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.Beneficios- Beneficios de acuerdo a la LFTSolicita este puesto directamente a través de nuestro portalSOLICITAR**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Carrera con título profesional**Inglés **Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** Si