Product Quality Analyst

Daily Documentation Control and Configuration Management (approximately 50% of time):

• Provides necessary support to ensure proper creation, coordination, filing management, storage, and retrieval of all controlled engineering and quality system documentation.
  
• Creates and maintains configuration for the Item Master List and Bill of Material (BOM); this includes consulting with Engineering Change Order originators to determine appropriate Item Master/BOM information based on engineering drawings and other product data.
  
• Maintains established product configuration identification system including part numbering, naming, nomenclature, etc.
  
• Trains appropriate AGA personnel on aspects of the documentation control system as required.
  
• Maintains currency of related databases.
  
• Assures that documentation conforms to appropriate AGA and Regulatory requirements.
  
  Daily Product Release to Finished Goods (approximately 50% of time):
  
• Leads the day-to-day processes associated with the release of products to Finished Goods.
  
• Compiles documentation in preparation for product release, ensuring information is present, accurate, and meets all requirements. When issues are identified, the Analyst leads resolution efforts.
  
• Assures microbiology laboratory receives documentation and product required to complete LAL and bioburden testing in a timely manner. Also reviews laboratory test reports for acceptability.
  
• Responsible for providing daily product release updates daily in Quality Log and upon demand
  
• Ensures that priorities and actions are transparent to cross-functional team members and that goals are being met; this will often involve reprioritizing efforts and balancing documentation control/configuration management demands with the day-to-day demands of releasing product.
  
• Serves as primary contact for sterilization documentation or laboratory documentation issues.
  
• Maintains a broad-based knowledge of Regulations, AGA SOPs and practices, and evolving regulatory trends; assesses them for impact on AGA and implements change accordingly.
  
• Writes, reviews, and approves procedures; updates product release procedures as necessary.
  
• Performs quality trending on a monthly basis. Recommends and implements improvements for better system utilization to improve efficiencies and minimize errors.
  
• Maintains a visual workplace, utilizing Lean 5S techniques.
  
  The successful candidate must possess the following educational and skill requirements:
  
• Bachelor’s degree in related field.
  
• Minimum 5 years experience in Documentation Control, Product Release, or combination thereof.
  
• Previous experience in the Medical Device or Pharmaceutical industry.
  
• Superior communication skills and proven ability to produce clear, accurate documentation.
  
• Ability to interpret engineering drawings and harmonize information with related technical documentation.
  
• Prior experience with Agile and JD Edwards preferred.
  
  
  

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We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.

An Equal Opportunity / Affirmative Action Employer

Please, No Agencies.