Sr. Quality and CI Engineer

About the Role:

• Provides continuous improvement engineering to support services organization under the Shyft Global Services brand.

• Is accountable for engineering support for continuous improvement, operating and design engineering for existing facilities, facility expansions and associated process design and documentation.

• Provides engineering support for customer facing interactions regarding new product releases and corrective action escalations.

• Leads service process validation activities and documentation for medical devices

What You'll Do:

• Engage in new project / product release activities compliant to medical device APQP processes when required. Ensure regulatory requirements are captured during development. (35%)

• Participate or lead internal ISO and regulatory reviews and audits. (15%)

• Develops, documents, and implements improved work methods, processes and procedures. (10%)

• Provides management of site level projects. (10%)

• Conducts work/method studies and develops appropriate reporting and recommendations. (10%)

• Provide document control administration activities including review and release control. (10%)

• Meets attendance and punctuality standards (10%)

• Lead cross location activities to normalize management system and process design and documentation across global service locations.

• Participates in continuous process improvement activities, including training and reporting.

• Primary owner for the development of new process documentation and facilitates change control of existing process updates as required.

• Participates and drives ISO compliance within assigned operations.

• Additional duties as assigned

What We're Looking For:

• Able to build solid, effective working relationships with others.

• Able to communicate clearly and convey necessary information.

• Able to constructively work under stress and pressure when faced with high workloads and deadlines.

• Able to create and conduct formal presentations.

• Able to execute instructions and to request clarification when needed.

• Able to exhibit ability to be sensitive to the needs, concerns, and feelings of others.

• Able to interact effectively with all levels of management.

• Able to maintain and promote social, ethical, and organizational standards in conducting internal and external business activities.

• Able to maintain confidentiality of sensitive information

• Able to perform basic mathematical calculations.

• Able to quickly learn new systems and technology.

• Able to recognize and attend to important details with accuracy and efficiency.

• Able to use relevant computer system applications at an intermediate level.

• Able to work independently with minimum supervision.

• Possesses basic clerical and data entry skills.

• Possesses strong leadership skills with a willingness to lead, create new ideas, and be assertive.

• Possesses strong organizational and time management skills, driving tasks to completion.

Required Experience and Education:

• Experience: 5 to 8 Years of relevant work experience.

• Bachelor's Degree in an Engineering field of study required.

• Other Education / Certifications: Lean Six Sigma, Continuous Improvement

Working Conditions:

• Distribution center / technical repair and manufacturing environment. Variety of environmental conditions and ESD / safety controls.

• Occasional non-standard work hours or overtime as business requires.

• Professional, office environment.

• Hybrid remote / on-site role (60% on site presence)

• Some travel required (15%).

Key Skills

Análisis de fallos, Análisis de medición, Análisis de modos de fallas y efectos del proceso (PFMEA), Calificación del proceso, Consultas de potencia, Cualificación de desempeño (PQ), Cualificación operacional, Documentaciones, Lenguaje de consulta estructurado (SQL), Mejoras de procesos, Planes de control, Planificación avanzada de calidad de productos (APQP), Proceso de mejora continua, Procesos de validación, Protocolos de validación, Tool Qualification, Validación de FDA, Validación de la calidad, Visualización de datos de Microsoft Power Business Intelligence (BI)

What’s In It For You?

• Elective Benefits: Our programs are tailored to your country to