Y detalle de las actividades
responsibilities: - implements policies and procedures to enhance the quality system, advises on methodologies regulating product quality: iso *:*, mdd and cmdcas, mdsap, cfr21 parts 820 and 11.
- coordinates and manages activities related to corrective and preventive actions, internal audits.
- plans, organizes, implements, and controls the internal audit program.
- prepares the site for receipt of external audits/inspections.
- audits the implementation and effectiveness of the corrective actions system.
- maintains and monitors the continuous process verification (cpv) process, working directly with quality engineering and process engineering areas.
- prepares monthly reports as required for management and corporate meetings.
- coordinates information for monthly quality meetings.
- organizes annual good practices training.
- maintains constant communication with corporate quality systems personnel to follow up on issues involving both sites, such as standards updates and impact assessments.
- coordinates, assigns, and controls activities of the calibration laboratory.
supports required quality activities to ensure the quality system remains active and updated.
experiência y requisitos
experience and requirements: education: bachelor's degree in industrial engineering, q.f.b., q.b.p, i.f. or related field.
specialization in quality systems desirable.
experience: 5 years or more in roles related to quality systems in medical device or pharmaceutical companies.
advanced english proficiency.
competencies: - knowledge of medical industry regulations and standards covered under mdsap (iso *, fda-qsr's, eu mdr, health canada, tga, etc.).
-application of risk management and iso *-based strategies.
cost reduction.
-development and implementation of controls and procedures for good documentation practices in regulated industries.
- mastery of administration tools and quality systems.
ability to develop, implement, and maintain corrective actions (capa) system in a regulated industry.
- standards and equipment calibration processes (iso/iec guide 98).
development and implementation of an internal audit program under iso *:*.
human competencies: problem-solving skills.
quality decision-making.
prioritization skills.
*número de vacantes* 1
*área* calidad
*contrato* permanente
*modalidad* presencial
*turno* diurno
*jornada* tiempo completo
*estudios* titulo profesional
*sexo* indistinto
*disponibilidad p.
viajar* no