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Manufacturing Quality Engineer. Job in North Chicago FOX8 Jobs

North Chicago, Illinois
Job Type
10 Jun 2022

Primarily responsible for quality assignments related to batch records, quality approvals, exception reports, metrics, and other documentation.


Review/approve/release batch record packets and associated documentation

Provide quality approvals of materials in the materials management system as defined by procedures

Write/review/approve exception documents and corrective actions/preventive actions (CAPA) and ensure they meet timeliness requirements

Review/approve clinical documentation and specifications, as applicable

Write/review/approve policies/processes/procedures and related documents

Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, R&D GxP Compliance

Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues

Generate, analyze and report quality metrics to management

Lead/participate with support groups in developing/prioritizing QA activity timelines

Actively monitor the effectiveness of processes and quality of project work with management, and propose and execute quality/process improvements

  • Qualifications:

    Bachelor's degree or equivalent experience is required, preferably in life sciences or engineering

    6+ years' experience in Quality Assurance or related field, preferred healthcare industry or experience in quality function

    Strong understanding of US and international regulations for quality systems and compliance

    Experience in coordination and planning of complex activities

    Proven organizational skills

    Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities

    Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues

    Ability to identify and resolve complex problems through effective use of technical and interpersonal skills

    Capable of clearly presenting and justifying quality requirements throughout all levels of management

    Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)

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  • Job Reference: 620977098-2
  • Date Posted: 10 June 2022
  • Recruiter: AbbVie
  • Location: North Chicago, Illinois
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent