Quality Engineer II

Title: Quality Engineer II

Location: Columbus, OH

Duration: 12 Months

Job Description

• The candidate will be responsible of first QA review of validation deliverables like validation change control, DQ documents (SIA, URS, FRS, DS, TM, and FMEA and risk assessment). The candidate as a Validation quality Engineer SME will coach and guide the workstream team through the validation lifecycle phases of the Pegasus project.
  
  

Main Responsibilities

• Drives alignment in cross functional meetings acting as QA representative on new and on market product design projects to ensure compliance with the design control process.
• Reviews and approves engineering changes in a timely manner.
• Review and approve validation deliverables like: DQ documents (SIA, URS, FRS, DS, TM, and FMEA and risk assessment), IQ, OQ, ES,PQ,PV,CV and variations.
• Foster a culture of GOOD Engineering Practices (GEP), Food Safety, U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, and compliance standards, Company policies, operating procedures, processes, and task assignments.
• Drives alignment during cross functional review and approval of impact assessments, root-cause analysis investigation and resolution activities.
• Reviews and approves batch records for products used in design verification/validation testing and clinical investigations.
• Ensures Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures.
• Collects, organizes, and monitors information related to quality and process improvement.
• Participates in internal & external audits and ensures audit responses are submitted in a timely manner.
• The candidate will foster a culture of GOOD Engineering Practices (GEP), Food Safety, regulatory and compliance standards.
• The candidate will be responsible to escalate to the Validation Governance validation topics requiring clarification or further guidance.
• The candidate will manage the quality validation activities of the area assigned.
  
  

Skills

• Open if they have experience in packaging, manufacturing, or facilities.
• Applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
• Regulated environment such as medical devices, pharmaceutical products, food manufacturing, aerospace, or automotive.
• M-files and Kneat
  
  

Education

• Bachelor’s degree
  
  

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.