Abbott Labs in Scottsdale is looking for a Sr Development Quality Engineer to do the following:
- Develop electronic component specifications, applicable component lot sampling plans, and associated qualification test requirements through collaboration with design, manufacturing, supply chain, and quality counterparts
- Support component selection and requirements for both development and sustaining projects
- Resolve supplier issues in cooperation with quality and supply chain.
- Helps plan and execute lab testing of components to verify performance and/or compatibility for use in new and existing products
- Supports sustaining engineering identifying alternate parts & manufacturers with form, fit and function equivalent analysis
- Support and ensure the establishment of objective, measurable, discrete, and verifiable component requirements
- Generate and/or support document change requests associated with development or sustainment activities in a timely manner
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Perform other duties and responsibilities as assigned by management.
- Communicate and present technical details to internal working groups and senior management as needed
- Support the development and maintenance of design controls and risk management files as needed
- Bachelors Degree (± 16 years) Engineering or Technical Field
- Masters Degree (± 18 years) Preferred
- OR an equivalent combination of education and work experience
- Minimum 5 years demonstrated use of Quality tools/methodologies. Prior knowledge of FDA, GMP, and ISO 13485 preferred.
- Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. Advanced computer skills, including statistical/data analysis and report writing skills.
- Prior medical device experience preferred. Experience in failure analysis or Destructive Physical Analysis preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.
If this sounds good to you, you can learn more about this role and access to the link to apply for it here.