Abbott New Product Development Quality Engineer I in Plymouth, Minnesota
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.
An operations quality engineer supporting new product development and design transfer activities. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will execute activities defined on design for manufacturability, risk management evaluation as well as process validation.
Also provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
Execute and support on-time completion of Design Control Deliverables
Accountable for Process Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Execute and support Risk Management activities from product Development through Commercialization
Support design and manufacturing test and inspection method development, and lead method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Leads technical activities for new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
Presents findings and recommendations.
Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
Understands engineering principles theories, concepts, practices and techniques.
Incorporates business policies and procedures into task completion.
Understands the business needs of the company, and has knowledge of the customer needs of our business.
Cultivates internal and external network of resources to complete tasks.
Serves as a resource in the selection orientation and training of new engineers and employees.
Supports project team(s), determines goals and objectives for the projects.
Interacts cross functionally and with internal and external customers.
Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
Acts as a spokesperson to customers on business unit current and future capabilities.
Bachelor's degree plus 2-4+ years of related work experience with an understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning
Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements
Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design
Training in blueprint reading and experience with sampling techniques
Good communication and computer skills, including data analysis and report writing skills
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