ESSENTIAL JOB DUTIES
• Perform raw material incoming inspections including and packaging material checks to ensure requirements are met— document and communicate results.
• Perform Daily Operating Inspections as needed to assure compliance with GMPs requirements.
• This position is responsible for day-to-day QA sampling collections that includes (but is not limited to) all sampling required for company bioburden control programs.
• This position will maintain accurate collection and record keeping of all sampling information, audit results and other project information.
• This position also performs scheduled facility audits and all documentation pertaining to those audits.
• Report and follow-up on quality concerns.
• Assists in customer concern investigations, including evaluation of retains, returned product, and raw materials to help determine concern validity and investigate root cause.
• Document establishment, review and approval
Required Qualifications
• Bachelor’s degree
• Relevant work experience in a medical device, pharmaceutical, or food processing industry field.
• Experience with FDA requirements, knowledge of regulations such as GMP, ISO 13485 and other international regulatory requirements preferred, but not required.
• Previous experience with Quality Management System development, implementation, and monitoring.
• Knowledge of quality systems, technical writing and training skills is preferred.
• A strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook.
• Excellent communication, organizational, analytical and interpersonal skills.
• Must be a person of passion and integrity who has the drive to excel and deliver exceptional results.

Highly qualified candidates will also possess:
• Previous experience working with the ISO 13485 quality management system
• Previous experience with FDA cGMP
• Experience with ISO and/or FDA audits
• The ability to solve practical problems or issues
• The ability to communicate and interact with coworkers in a positive manor
• The ability to work swiftly and accurately
• The ability to recognize and solve practical problems or issues