Quality Engineer

_The Quality Engineer will be responsible for providing Quality Management System compliance support for Centerpiece. The scope of this role encompasses activities related to Documentation Control, Change Control, Corrective Action Systems, EQMS Implementation & Administration, Field Actions/Recall, Internal Audits, support Validations and maintenance of Quality Metrics. In this capacity, the Quality Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance. _- Moreover, will work closely with the operations team to ensure all manufacturing activities are compliant to 21 CFR Section 820, EN ISO 13485, Environmental Standards, and other as necessary operating requirements. _- This role will support Centerpiece’s growth and Centerpiece’s operational excellence strategies by ensuring compliance to its quality system. This position will also routinely interact with the production operations team._- The Quality Engineer will:_- _Support all programs and initiatives related to the ethics code and Company values and core belief _- _Monitor, guide and as necessary direct on the adequacy and continual improvement of each sites ISO aligned EHS Management System._- _Perform a New Product introduction activities supporting Quality Engineering using QMS. _- _Generate Quality Work Instructions and Forms_- _Develop a validate test methods_- _Contribute to validations (executing or coordinating)_- _Perform, Maintain and Sustain activities under QMS supporting Quality Engineering _- _Ensure that CAPA, NCMs and Customer Complaints are addressing in a timely manner _- _Perform a testing activities and records _- _Coordinate and/or contribute in DMR and DHRs. _- _Perform a quality alerts and coordinate low risk investigation for NCM, CAPA and Customer Complaints _- _Monitoring on Key Performance Indicators _- _All other activities assigned by direct report and related with the organization._- _Supports all external third-party quality system inspections and audits (FDA, Notified Body, International Regulatory Agencies, etc.)._- _Trains Centerpiece personnel on Quality System Compliance to ensure procedures and processes are properly followed and documented._- _Supports the investigation and management of Customer Complaints._- _Prepares technical reports, certificates and presentations as needed._- _Communicates with engineering and production departments on developing and improving compliance._- _Coordinate Document Control Module in Grand Avenue Software and maintenance control of customer labels_.- **QUALIFICATIONS**_- Required Knowledge, Skills, and Experience:_- _Commitment to product quality, the Centerpiece quality system, and all applicable regulations (Federal, Local, and State)._- _Bachelor’s degree in business, engineering, or related scientific discipline._- _Expertise on Quality department for a minimum of 3 months._- _Ability to successfully manage multiple projects simultaneously._- _Has professional presence with a level of comfort interacting with associates at all levels of an organization (internal and external), including executive management._- _Fosters and actively contributes to a positive team working environment._- _Is a highly motivated, self-starting person who takes pride in the quality outcome of their work._- _Excellent interpersonal skills and a collaborative management style._- _A demonstrated commitment to high professional ethical standards and a diverse workplace._Tipo de puesto: Tiempo completoSueldo: $765.49 - $1,500.00 al díaBeneficios:- Descuento de gimnasio- Estacionamiento de la empresa- Opción a contrato indefinido- Seguro de gastos médicos mayores- Vales de despensaTipo de jornada:- Diurno- Lunes a viernes- Turno matutinoPuede trasladarse/mudarse:- 22706, Rosarito, B.C.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)Experiência:- Industria Medica: 1 año (Obligatorio)- NCMRs, CAPAs, Validaciones, TMVs: 1 año (Obligatorio)- Root Cause Analysis Tools.: 1 año (Obligatorio)- Validations (IQ, OQ, PQ, TMV): 1 año (Obligatorio)- Statistical Method Application.: 1 año (Obligatorio)Idioma:- Inglés (Obligatorio)Lugar de trabajo: Empleo presencialFecha de inicio prevista: 22/04/2025