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 Management System Support
  • 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.
  • Project Coordination and Management of Quality Assurance projects across multiple departments and functions.
    • Lead and coordinate Quality Assurance projects across multiple departments and functional areas.
    • Plan, track, and execute QMS transformation initiatives, including:
      • Implementation of electronic Change Control processes
      • Implementation of electronic Nonconformance and deviation or temporary change processes
      • Migration of quality records and workflows from legacy systems to new electronic QMS platforms
    • Develop and maintain project plans, timelines, milestones, and status updates for QA system initiatives.
    • Coordinate cross‑functional stakeholders to ensure project objectives, regulatory requirements, and timelines are met.
    • Identify risks, dependencies, and resource needs associated with QA projects and escalate as needed.
    • Support project validation, user readiness, and training activities related to electronic QMS implementations.
  • 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.
  • Design Quality Engineering
    • Provide guidance, support, and approval during the design and development stages of products.
    • Ensure, through coordination with Manufacturing Engineering, new and existing products are manufacturable. Assists in Design Transfer activities.
    • Ensures compliance with internal and external requirements throughout the design control process.
    • Perform process risk assessments for existing and new products.
  • Supplier Quality
    • Assists in evaluating and monitoring suppliers.
    • Supplier audits.
    • Provides data analysis to support supplier qualifications.
  • Health, Safety, and Environmental
    • Support activities related to Health, Safety, and Environmental policies.
  • 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. Provides excellent data analysis techniques to assist in the accurate evaluation of the QMS.
    • Assists with related special projects, as required.

Qualifications

• Bachelor's degree (B.S.) degree in Life Science or Engineering discipline plus five (5) years quality relatedexperience in manufacturing industry; or five (5) years of direct Quality or Regulatory related experience. Practical experience/training in quality planning, Corrective/Preventiveactionsystems, qualityauditing, rootcauseanalysis, statistical analysis, and problem solving are highly desirable. Certified and/or experienced Quality Engineers preferred.
• Experience with implementation of eQMS.
• Good knowledge and skills in the use of advanced personal computer productivity programs for wordprocessing,spreadsheets,databasemanipulation, and flow Off-the-shelf process software implementation/maintenance preferred.
• DemonstratesworkingknowledgeofISO13485qualitysystem and/orFDA21CFR 820 quality MDSAP and EU regulation experienced preferred.
• 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.