Manufacturing Quality Engineer

Lake County, Illinois
Jun 09, 2022
Required Education
Bachelors Degree
Position Type
Full time

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)