Development Quality Engineer II

Title: Development Quality Engineer II

Location: St. Paul, MN

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

• Support preparing Regulatory Submission documentation and responding to questions from Regulatory Agencies.
• Additional duties may be identified by functional management based on current project/business objectives.
• 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.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  
  

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.