Abbott Quality Engineer II in Sylmar, California
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.
We are seeking an experienced, high caliber Quality Engineer II to join our Abbott Sylmar Operations Quality Engineering team.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Essential job responsibilities:
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Design and conduct experiments for process optimization and/or improvement.
Appropriately document experiment plans and results, including protocol writing and reports.
Lead process control and monitoring of CTQ parameters and specifications.
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
Lead the investigation, resolution and prevention of product and process non-conformances.
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Lead in the completion and maintenance of risk analysis.
Work with design engineering in the completion of product verification and validation.
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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’s degree in Engineering or Technical Field
Minimum 2 or more years of Engineering experience and demonstrated use of Quality tools/methodologies
knowledge of FDA820, GMP, ISO 13485, and ISO 14971
Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues
MS or higher degree in a technical discipline
Advanced computer skills, including statistical/data analysis and report writing skills
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
medical device experience
ASQ CQE or other certifications
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com