Pay Type: Exempt
Department: Sales
EEO Type: Professional

 

Summary:

Quality Engineer within the Quality Department, communicating problems, situations, opportunities, and progress to Quality Manager. Assisting with Validation programs, Change Control Process and CA/PA Tracking Program. Participates in audits for compliance to customer and regulatory/GMP requirements.

Primary Responsibilities:

  • Interface with FDA and third-party auditors during inspections
  • Provide guidance to assist in the development, implementation, and maintenance of the Quality Management System
  • Lead the Internal Audit Program
  • Lead / Assist quality system audits to ensure the QMS operates in a state of compliance and continuous improvement
  • Prepare audit reports and conduct audit briefings upon completion of audits within specified time frames and generate audit corrective action requests as applicable
  • Monitor internal audit non-conformances, perform trend analyses, and present findings
  • Analyze and monitor quality data to identify potential issues and implement necessary actions to mitigate compliance and product risks
  • Oversight of the CAPA Corrective and Preventive Action program to ensure documentation of investigation, Root Cause conclusion, respond to customer, trending, “Effectiveness Verification” completion.
  • Contribute to the development and improvement of audit program metrics

Other Required Skills and Abilities:

  • Knowledge of Good Manufacturing Practices
  • Validation Experience with packaging equipment SAT’s, IQ/OQ/PQ.
  • Excellent interpersonal, presentation and business communication skills.
  • Detail oriented; ability to catch mistakes.
  • Quick learner and creative problem solving skills.
  • Excellent organizational skills.
  • Ability to react quickly to unexpected occurrences.
  • Requires positivity, initiative, and self-motivation.
  • Ability to work independently with minimum supervision.
  • Ability to work on a team and exchange ideas.
  • Ability to make company minded decisions based on ethic, effort, and reliability.

Required Skills

  • Bachelor’s degree in Engineering or Science
  • Demonstrated understanding of industry regulations, including detailed knowledge of FDA/ISO 13485
  • Significant work experience in Quality System Auditing
  • 3+ years of work experience in Quality / Compliance within a regulated industry
  • Proficient in Microsoft Excel and other computer programs

Ready to Apply?

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