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.
- 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.
- 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
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