Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
The Principal Quality Assurance Engineer is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within new product development, manufacturing, or system/services support.
•Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel.
•Leads multifunctional teams in completing program directed or continuous improvement activities.
•Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
•Leads the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
•Leads the development and execution of streamlined business systems which effectively identify and resolve quality issues
•Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
•Designs and conducts experiments for process optimization and/or improvement.
•Appropriately documents experiment plans and results, including protocol writing and reports.
•Leads process control and monitoring of CTQ parameters and specifications.
•Leads and implements various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
•Leads the investigation, resolution and prevention of product and process nonconformance.
•Leads teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
•Leads in the completion and maintenance of risk analysis.
•Works with design engineering in the completion of product verification and validation.
•Works with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
•Develops and applies an expert understanding of designated systems as well as serves as a subject matter expert for the development quality team regarding behaviors, implementation trade-offs, customer needs, satisfaction of customer needs, clinical applications, and the applicable technologies required to solve problems and deliver upon business objectives. Participates in broad cross-functional reviews of work output.
•Fosters collaboration with cross-functional teams, platform architects and other leaders to drive work to completion and resolve issues. Successfully influences stakeholders. Communicates effectively with cross-functional teams and senior management. Keeps leadership informed of progress and issues.
•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
•Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Bachelor Degree in Engineering or Technical Field or an equivalent combination of education and work experience. Advanced degree preferred.
- Minimum 10 years related work experience.
- Demonstrated strong project management skills, experience leading global projects preferred. Demonstrated supervisory experience. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- Solid communication and interpersonal skills. Strong 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. Demonstrates technical leadership within the department and outside the department. Advanced computer skills, including statistical/data analysis and report writing skills
- Prior medical device experience. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- 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 organizational and follow-up skills, as well as attention to detail.
- Ability to travel including internationally.