Quality Systems Specialist

Summary

Supports the creation, development, management, maintenance, control, and overall improvement of the Quality Management System and corresponding processes, procedures, work instructions, and records.

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).

• Quality Management System Support

• Corrective and Preventive Action (CAPA)

• Performs investigative research and trend analysis of complaints, discrepant material, process control variations, and other quality-related issues to understand and identify areas for improvement.

• Compiles information and uses various improvement tools (Lean, Six Sigma, etc) and statistical techniques to assess and determine root cause of problems.

• Initiates corrective or preventive action and solicits approval through the CAPA process for all proposed actions.

• Implements corrective or preventive action through formal change control.

• Compiles, analyzes, and tracks the implementation of CAPA plans and reports results to key stakeholders.

• Assesses the effectiveness of all corrective and preventive actions.

• Nonconforming Product

• Oversees and champions the routine effort to identify, track, control, and quarantine all nonconforming products.

• Conducts reviews to determine the source and root cause of nonconforming products to prevent reoccurrence.

• Conducts risk analysis to ensure proposed product disposition is appropriate and acceptable.

• Reviews and approves all NCR dispositions.

• Complaint Handling

• Investigate all complaints.

• Determines if complaints require specific action including but not limited to product recall, adverse event reporting, regulatory notification, etc.

• Conducts trend analysis to identify reoccurring issues that should be addressed through formal corrective or preventive action or change control.

• 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 processes and procedures.

• Other

• Participates and supports the control of all inspection, measuring, and test equipment.

• 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 the manufacturing industry; or five years of direct Quality or Regulatory related experience. Practical experience/training in quality planning, Corrective/preventive actions systems, quality auditing, root cause analysis, and problem-solving are highly desirable. Experience in implementing eQMS software, or years of experience using eQMS software is highly preferred.
• Good knowledge and skills in the use of advanced personal computer productivity programs for wordprocessing, spreadsheets, database manipulation, cloud-based software, and flow
• Demonstrates working knowledge of ISO13485 quality system and/or FDA 21 CFR 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

Work Environment

While performing the duties of this job, the employee is not exposed to environmental conditions. The noise level in the work environment is usually moderate.