Quality Assurance Specialist

Position Summary

The Quality Assurance Specialist will provide quality engineering support to develop and improve products, manufacturing processes, equipment, and systems by working with engineering to define specifications, materials and manufacturing procedures. In a product development capacity, this psition will provide quality assistance under appropriate direction amd in all technical phases of product development including design and development planning and requirements definition.

Principal Responsibilities

• Under appropriate direction, support the Arrow Logistics and Distribution Team by reviewing changes initiated by engineers that implement products into manufacturing; including developing and applying processes, equipment, and manufacturing capabilities.

• Support Logistics and Distribution by improving existing logistics products or processes. Interface with marketing, physicians, and customers as necessary to solve problems and complete logistics projects.

• Assist Logistics and Product Line Extension (PLE) projects by providing quality engineering support on design control activities.

• Perform/participate in product, process, and quality system audits, if needed.

• Support the Logistics Team for new component/new assembly qualifications. This includes providing quality engineering support on verification and validation activities for new and existing products and components.

• Identify variations and determine solutions to improve internal processes, including but not limited to design control procedures.

• Provide other departmental support as requested by immediate supervisor and Logistics leadership.

• Ensure quality of components is maintained during the transfer of parts, assemblies, documentation, and processes from prototype stage through pilot to production.

• Aid the project teams in meeting project objectives, milestones, and target dates. Monitor and communicate progress on quality objectives as required by supervisor.

• Interface with vendors during requests for information and to debug problems with production parts.

• With the Logistics department, interface with purchasing and marketing to establish vendor supply agreements for components and/or new products.

• Establish and maintain cooperative working relationships within the Logistics Team.

• Ensure compliance of all practices with the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.

• Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.

• Perform root cause analysis of identified issues and determine appropriate corrective and preventive actions. Use the NC and CAPA systems as needed to structure activities.

• Define, identify, and apply product and process control methods such as developing control plans, identifying essential design outputs and critical control points, and developing and validating work instructions.

Education / Experience Requirements

• MUST have one of the following careers: Ingenieros titulados y con cédula QFB, QFI, IBM, IBQ, IF
• Business english proficiency
• 2 to 5 years of Quality Engineering or Design Assurance experience in the medical device industry, preferrably having worked at warehousing related operations.

Specialized Skills / Other Requirements

• Basic understanding of industry regulations such as NOM 241 ISO 13485, ISO 14971 

• Proficient in MS Office, and Minitab or other statistical software. • Strong organizational and time management skills to meet deadlines while managing multiple projects. • Strong analytical and critical thinking skills.

• Proficient in technical report writing and review.

• Strong verbal and written communication skills.

• Foster a positive culture of growth, collaboration, and achievement across the organization.