Quality Systems Specialist

Summary

Supports the development, management, maintenance, control, and overall improvement of the Quality Management System and corresponding processes, procedures, work instructions, and records. Key responsibilities to the Nonconforming Product (NCP) process and the Inspection, Measuring, and Test (IMT) equipment process.

Essential Duties and Responsibilities

• Quality Planning
  • Writes and executes quality plans.
  • Establishes Quality Control points that are used to monitor progress and achievement of quality plans.
  • Integral part of the implementation and continued support team for an electronic Quality Management System (eQMS), specifically for the NCP and IMT processes.
• Quality Management System Support
• Nonconforming Product
  • Oversees and champions the routine effort to identify, track, control, and quarantine all nonconforming product.
  • Conducts reviews to determine the source and root cause of nonconforming product to prevent reoccurrence.
  • Conducts risk analysis to ensure proposed product disposition is appropriate and acceptable.
  • Reviews and approves all NCR dispositions.
  • Assists in implementing electronic system for the NCP process.
  • Maintains documentation and records.
• Inspection, Measuring, and Test (IMT) equipment
  • Oversees and champions the routine activities for the calibration of IMT equipment.
  • Conducts in-house calibration of equipment and facilitates out-of-house calibration.
  • Performs investigations during an event of out of calibration for any piece of equipment.
  • Maintains documentation and records.
  • Assists in implementing electronic system for the IMT process.
• Corrective and Preventive Action (CAPA)
  • Escalates any issues arising from key responsibilities to the CAPA program.
  • Assists, as needed, the Quality Engineer in performing investigations, Corrective or Preventive actions, and/or effectiveness checks.
• Complaint Handling
  • Assists in review of complaints, as needed.
  • Assists in performing actions related to complaint outcomes, including (but not limited to): communication to production, training activities.
• Internal Audits / External Audits
  • Conducts internal audits according to the internal audit schedule or as assigned.
  • Prepares audit checklists, conducts interviews, and records observations, opportunities for improvement, and audit nonconformities in a formal Audit Report.
  • Follows up and clears down all audit nonconformities in future internal audits.
  • Participates in External Audits as assigned.
• Quality Training
  • Consistently provides quality training to individuals throughout the company.
  • Provides role model behavior regarding adherence to process and procedure.
• Process Control and Quality Improvement
  • Reviews quality and operational processes including manufacturing and QC to ensure processes are adequately controlled.
  • Prepares appropriate quality control points throughout the facility to provide evidence that processes are in control.
  • Works with department supervisors to identify opportunities for improvement.
  • Implements improvements that reduce variation and improve overall quality.
• Document Control and Record Control
  • Supports the document control team as assigned.
  • Establishes and maintains records of all actions according to established process and procedure.
• Other
  • Helps to monitor the progress and implementation of quality objectives.
  • Regularly tracks and updates key performance indicators, which are used to assess the overall effectiveness of the Quality Management System.
  • Assists with related special projects, as required.

Qualifications

• Bachelor's degree (B.S.) degree in Life Science or Engineering discipline plus three years quality related experience in manufacturing industry; or five years of direct Quality or Regulatory related experience. Practical experience/training in quality planning, NCR systems, Calibration programs, Corrective/Preventive action systems, quality auditing, root cause analysis, and problem solving are highly desirable. Experience in implementing eQMS software, or years of experience using eQMS software highly preferred.
• Metrology requires an understanding of equipment usage, data analysis, units and unit conversion, regulatory requirements, and industry best practices. Certification required, or provided after hire.
• Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, data base manipulation, cloud-based software, and flow.
• DemonstratesworkingknowledgeofISO13485qualitysystem and/orFDA21CFR 820 quality.
• This position interfaces with all levels of the organization, management and staff, and with customers and suppliers; confidentiality is important to this job position.