Quality Manager

Descripción y detalle de las actividades- Expertise and compliant development of production and process controls, risk management plans, product specific quality plans and control strategies along with the execution of these plans through clear and concise quality procedures and quality records established and maintained utilizing good documentation principles- Ensure all commitments and obligations defined in customer quality agreements are understood and consistently met by individuals/functions at the sites.- Ensure all change control activities are performed in a compliant manner, especially those changes that require customer notification and/or approval prior to implementation- Establish sampling plans, develop and validate production processes and test methods with demonstrated documented capability- Ensure first article reports on all new molds are completed per local requirements and in accordance with customer expectations which includes full dimensional evaluations as required- Ability to build, manage, lead, train and develop the quality team and collaborate with the internal and external teams to ensure product safety, efficacy, and quality- Well-developed teamwork and collaboration and ability to communicate clearly and effectively. Provide team members with feedback related to their performance and recommendations for improvements.- Ensure internal quality system audits, executed, and documented in accordance with the medical device and automotive regulations and, local quality management system.- Ensure efficient workflow of product inspections during all shifts.- Maintain quarantine area and product disposition to prevent unintended use of nonconforming product- Other duties as requested directed or assigned.Experiência y requisitos- Bachelor's degree in Engineering, Quality, or Science related field; plus, minimum, 7 years of experience in a quality discipline. A minimum of 5 of those years should have been in a managerial/decision-making capacity- Thorough knowledge of plastic injection molding and assembly processes.- Strong technical writing and reviewing skills.- Minimum 5 years in a leadership role in an injection molding environment preferred- ASQ “Certified Quality Manager,” “Certified Quality Auditor” preferred- Knowledge of Federal, State, and Local environmental health and safety requirements- excellent computer skills using Excel, Access, Word, statistical software.- Strong mechanical aptitude and organizational abilities- Ability to promote a Team atmosphere and demonstrate ability to lead a team to complete more and tasks on time- Ability and knowledge to operate all inspection equipment in the department- Quality of all product run/shipped (zero defects to customers- Overall Customer Satisfaction: Quality, Delivery, Responsiveness- Profitability of department: Overtime, Decision Making- 100% On-time delivery of all inspections as required- Meet scheduled hours and dates of all tasks, with the goal of completing tasks ahead of schedule.- Utilize machinery & prioritize equipment usage to obtain the quickest lead times- Assist in the development and execution of validation structure and procedure- Maintain an attitude of Continuous Improvement.- Maintain a department that is neat, organized, and clean at all times- Goal is a self-sustaining department to meet all requirements of your internal customer at Westfall TechnikBeneficios- utilidades garantizadas- servicios médicos en planta- Seguro de Gastos Medicos Mayores**Número de vacantes** 1**Área** Producción/Manufactura**Contrato** Permanente**Modalidad** Presencial**Turno** Variable**Jornada** Tiempo Completo**Horario**- Tiempo completo**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** Si