Abbott Senior Development Quality Engineer in Plymouth, Minnesota

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

  • Lead on-time completion of Design Control Deliverables

  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities

  • Lead Risk Management activities from product Concept through Commercialization

  • Support design test and inspection method development, and lead method validation activities

  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

  • Support manufacturing process development & qualification for new product commercialization and product changes

  • Support and ensure internal & external audit responses

  • Support and ensure on-time product re-certifications

  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements

  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications

  • Accountable for development, execution and analysis of biocompatibility and sterilization qualifications

  • Complete Document Change Request Reviews in a timely and objective manner

  • Develop and lead other team members.

  • Perform other duties and responsibilities as assigned by management.

  • 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.

  • 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.

  • Performs other related duties and responsibilities, on occasion, as assigned.

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 corpjat@abbott.com