What are the responsibilities and job description for the Development Quality Engineer II position at Abbott?
Title : Development Quality Engineer II
Location : St. Paul, MN
Duration : 12 months
Primary Responsibilities :
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead on-time completion of projects supporting quality and business initiatives.
- Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
- Lead Risk Management activities including analyzing field data to update Risk Management File documents such as, Failure Modes and Effects Analysis (FMEA), Hazard Analysis, and Risk Management Plan / Report.
- Support Test and Inspection Method development including Method Validation activities.
- Accountable for Design Verification and Design Validation planning and execution, including cross-functional root-cause investigation and resolution activities.
- Support manufacturing process development and qualification for design changes.
- Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
- Lead and support Corrective Action Preventive Actions (CAPAs) in a timely and objective manner.
- Lead, coach, and mentor junior engineers.
- Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, Regulatory, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
Other Responsibilities :
Experience : 2-5 years.
Skills : Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills
Education : Bachelor level degree in an Engineering Discipline or other technical field experience
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, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
