Quality Manager
hace 2 semanas
**Descripción y detalle de las actividades**
- This position is responsible for providing leadership and is assigned the authority to implement, coordinate and monitor the facility’s Quality System as it pertains to contract sterilization of medical devices. Acts as the facility’s Quality Representative, ISO Management Representative, and lead Quality System contact for all activities related to the facility as directed by the Director Sterility Assurance with a commitment towards quality, accuracy, and process improvement.Has authority and responsibility to represent the facility on all quality matters pertinent to the Quality Management System as established through customer and regulatory requirements as well as organizational quality policies and procedures.Implements and communicates new or revised Quality System/Regulatory Compliance policies and procedures.Ensures that QSR and ISO regulations are adhered to. Maintains a working knowledge of regulations and establishes a monitoring program that responds to audit activity in a constructive manner.Ensures that all processing records are in compliance with processing specifications and Quality Systems/Regulatory Compliance requirements prior to product release. Has authority and responsibility to withhold release approval for customer product not meeting acceptance criteria. Should a question arise regarding product release or in regards to the quality of the product, service provided or regulatory issue, the issue will be discussed through appropriate management channels, ultimately to be brought before the Director Sterility Assurance for resolution.Ensures the customer processing specifications are current and readily available to the facility production staff.Ensures process control through review of operations, calibration, maintenance documents. Ensures that record keeping requirements are met and that good documentation practices are followed. In addition, reviews and maintains instrument calibration and qualification documentation to ensure tests are performed according to approved.
**Experiência y requisitos**
- BS Degree in scientific or engineering background or equivalent experience in Quality/Sterilization industry preferred. Master degree preferred.A Minimum of five (5) years of experience in medical device manufacturing or in sterilization operations, Quality System FDA regulations (QSR), and validation is preferred.A minimum of two (2) years of supervisory or management experience.English 90%Office Windows: Word, Excel, Power Point, (intermediate skill level)SAP, AS400 DesirableSkills:Ability to make decisionsAbility to work independently under general guidelines and supervisionAbility to work independently under general guidelines and supervision.Ability to influence people in their opinions, attitude or judgements; Ability to generalize, evaluate and make decisions in stressful situations.Excellent organizational habitsManagement of personnel and work teamsManagement and solution of conflictsEffective interpersonal skills as demonstrated through prior management experienceSelf-Motivation
**Organización**
- Medline**Giro**
- Manufacturera**Actividad principal**
- Global manufacturer and distributor of medical products with patient-centered solutions.**Número de empleados**
- 2500**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Titulo Profesional**Sexo** Indistinto
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