Quality Engineering Consultant II #8807

Brief Description

ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About This Role

The Quality Engineering Consultant will enhance production processes to ensure efficiency, quality, and safety. This role requires collaboration with cross-functional teams, strong problem-solving abilities, and a deep understanding of manufacturing systems to drive success. This role is an onsite role.

What You'll Do

• Contribute on projects to provide solutions to engineering challenges, ability to effectively perform under supervision or minimal supervision, documents goals and objectives to monitor action plans.
• Demonstrate knowledge and applies current quality, regulatory, and industry knowledge to project deliverables, is capable of being self-taught. Is focus on achievement, recursive and can identify engineering problems, anticipate client´s needs and utilizes analytical and conceptual thinking to provide innovative and creative solutions.
• Demonstrate costumer service orientation and focus its work efforts on becoming the client´s "trusted advisor" by building trust and providing client satisfaction through effective responsiveness, punctuality, confidentiality, professionalism and responsibility.
• Adapts to the changes in work and to the customer needs, communicates with assertiveness, has ability to handle difficult clients with diplomacy and demonstrate ability to create and maintain internal and external functional interpersonal relationships.
• Is proactive and uses projects and other opportunities to further develop technical, business and professional skills.
• Successfully contribute to projects teams according to the engineering necessity of the client, including activities like product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, process/test documentation, etc.
• Experienced and proficient with quality documentation in order to develop, review and approve quality documentation such as: design verification, design validation, process validation, quality plans, standard operating procedures, and inspection procedures.
• Identify device improvement opportunities of quality, cost, performance and contribute to projects to apply systematic problem-solving methodologies. Identify, prioritize, communicate and resolve quality issues, build quality into all aspects of work by maintaining compliance to all quality requirements.
• Fabrication and evaluation of materials, components, devices, text fixtures and prototypes.
• Analyze and identify opportunities for continuous improvement in the process, and its respective implementation with minimal supervision.
• Provide support in validations for the design area.
• Collaborate with the compliance and monitoring of KPIs.
• Work according to the guidelines of the EHS department.
• Ensure that product and process development changes to existing products and manufacturing lines are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations and other applicable standards.
• Maintains own project schedules and priorities, plans and organizes project assignments under supervision or minimal supervision.
• Provide work direction to junior-level engineers, technicians and cross-functional specialists.
• Participate in meetings and presentations. Work cohesively and maintain functional interpersonal relationships with internal and external customers.
• Demonstrate customer service orientation, translate customer requirements into workable product ideas and solutions.
• Adapt to the culture, policies and procedures of the client´s company, be recursive and create strategic alliances to facilitate completion of the assignments.
• Maintain active communication with supervisor and client.

What We're Looking For

• Bachelor's Degree in Engineering.
• 5 – 7 years of experience.
• Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio) Proficient in the use of Minitab statistical analysis.
• Experience with SolidWorks, ProE or Inventor, prototypes, 3D (desirable)
• Familiar with electronic management documentation.
• Spanish: Native Speaker, English: Fluent speaking, writing and reading.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.