Quality Assurance Engineer 4 CR

Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

• Responsible for the NCE program including managing divisional non conformances through the lifecycle, publishing status reports, and hosting MRB review board meetings. Ensure consistent application of NCE processes across sites and manufacturing partners. Support escalation and investigation of significant nonconformances impacting product quality or regulatory compliance. Mentor NCE owners in the investigation, documentation, root cause analysis, resolution and escalation of nonconformities. Ensure alignment of the NCE process with QMSR and ISO 13485 requirements. 

• Supports for the development and maintenance of manufacturing transition procedures including procedures related to design transfer, change control and monitoring. Act as SME for design transfer activities, ensuring effective transfer of product from development into manufacturing. Responsible for establishing and maintaining procedures to ensure manufacturing processes and specifications are correctly implemented and aligned with design requirements.

• Establish and maintain quality oversight processes for internal contract manufacturing sites. Monitor production performance metrics, non-conformances, CAPAs, complaints and audit findings of internal contract manufacturers as input for Management Review. Coordinate issue resolution and corrective actions impacting product compliance. 

• Acts as liaison between the divisional quality assurance team and the Supplier Quality Engineering organization for activities involving external contract manufacturers and OEMs. Supports onboarding of GSS suppliers, review of Quality Agreements and approval of Supplier Status events. Supports investigations, containment activities and corrective actions related to supplier quality issues. Facilitate communication and alignment between the divisional quality team the Supplier Quality Engineering team. 

Supervisory Responsibilities: 

• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. 

Qualifications / Cualificaciones: 

• Strong knowledge of design transfer, process validation, and change control within regulated industries 

• Analytical skills for data-driven decision making and process monitoring 

• Excellent written, verbal, and presentation skills. 

• Demonstrates independent decision making and prioritization, including independent resolution of conflicts 

• Effective cross-functional collaboration and communication skills. Ability to influence across functions and drive changes.

Education / Educación: 

• Technical bachelor’s degree. 

Experience / Experiencia: 

• 8 plus years’ experience preferably in medical device industry. 

   

• Experienced with FDA Quality System Regulations, ISO 13485, MDSAP, Medical Device Directive and Medical Device Regulation.

   

Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): 

• N/A

Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):

•  English level B2+ / Spanish Advanced

Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: 

• Proficient with MS Office tools including Excel, PowerPoint and Word.