Quality Assurance Coordinator Jobs

Description:

Coordinate the cross-functional management and execution of required activities within designated area(s) of the Quality Management System (QMS).

Requirements:

Essential Duties:

• Manage the response to audit items from the response performance of designated Quality Assurance process activities: non-conformities for related QMS processes, as needed.
• Support the complaint process activities as needed.
• Inspect production records (batch records, bar code labels, inspection sheets) and visually confirm a sample for each finished good.
• Inspect and disposition returned goods to determine fitness for use.
• Participate in external audits (ISO, FDA, etc.) as a subject matter expert for related QMS processes, as needed.
• Support process trouble / CAPA investigations activities, as needed.
• Drive the execution of daily management for related QMS processes, taking required action to investigate trouble reports and implement improvements.
• Support the assignment and verification of trouble reports to responsible associates based on issues occurring within related QMS processes.
• Participate in GQM improvement activities, including high-priority KI projects, as needed.
• Ensure compliance with all established procedures and quality requirements, investigate and resolve discrepancies.
• Track non-standard batch numbers (e.g., multiple batch pairings and/or kit component updates) to assure conformance with batch pairing and/or kit component procedures.
• Provide Quality Management System training to operations and other departments, as needed.
• Prepare standard reports and KPI data and submit them to peers and/or superiors according to planned arrangements.
• Prepare and submit data and related evidence for QMS Management Reviews.
• Approve batches for release:

Minimum Qualifications

• 3+ years of experience in a regulated industry (Med Device, Food, Drug, etc)
• Demonstrated understanding of Quality Management System requirements (ISO, FDA, GMP, etc)
• Skills with QC tools & techniques is preferred but not required (Control Charts, Histograms, Pareto diagrams, Cause & Effect diagrams, Process Flow Diagrams, Check sheets, Scatter Diagrams, etc.)
• Experienced in technical report writing and analytical skills
• The ability to communicate with peers in operations to share information, hold nonconforming items, engage on problem-solving activities.
• Working knowledge and understanding in the use of standard work / SOPs.
• Skilled in Microsoft 365 tools and technology

Education: BA/BS Degree in science, engineering or related field is preferred. Equivalent experience in Quality related or adjacent role will be considered.

Experience and/or Training: 3+ years of related Quality Management System experience. Quality certification (ASQ, etc.) is a plus.

Benefits:

• Company Paid Life Insurance two times annual salary
• Dental insurance with Delta Dental PPO
• Tuition reimbursement
• Paid time off, including extra paid week off the week between Christmas and New Year
• Health insurance BCBS Illinois PPO
• Vision insurance EyeMed
• Employee assistance program
• 401(k) through Fidelity and company matching 10%
• Health savings account