Quality Assurance Manager

4 days ago

Covington, Georgia, United States BD (Becton, Dickinson and Company) Full time
Job Summary:

This position will be responsible for managing all aspects of quality within our manufacturing operations in Covington, Georgia. This includes supporting product development projects to meet business objectives, ensuring compliance with internal and external regulations and standards, and maintaining high levels of customer satisfaction.

Responsibilities:
  • Manage all aspects of quality within our manufacturing operations including but not limited to:
  • Ensure products are designed to meet customer needs and expectations by participating in design reviews and other project activities; ensure effective product/process transfer into production
  • Conduct risk assessments as needed to identify potential issues prior to implementation
  • Develop inspection methods and sampling plans according to established procedures or in consultation with applicable departments such as engineering, manufacturing, purchasing etc.; provide training on these topics as required
  • Lead audits conducted by customers or regulatory agencies such as FDA, MDD, CE Mark etc.; ensure appropriate documentation and follow up actions are completed
  • Review nonconformances (NCs), complaints and corrective action reports generated during production or post market surveillance activities; determine root cause analysis and corrective/preventative action plan where necessary
  • Monitor performance metrics such as scrap rates, defect per million opportunities (DPMO), process capability index (CPK) etc.; implement improvements based on trends identified
  • Investigate product failures and adverse events associated with our products through review of available data sources including but not limited to complaint files, product liability claims etc.; report findings internally and externally when appropriate
  • Support customer service organization in resolving product-related questions from healthcare professionals or patients
  • Coordinate rework activities related to NCs or other quality issues; ensure timely completion of Rework Notifications (RNs) and Corrective Action Reports (CARs)
  • Oversee maintenance programs for equipment used in manufacturing processes
  • Provide input on new technology evaluations which may affect current operations
Qualifications:
  • Bachelor's degree in engineering, science or related field required
  • 5+ years of experience working in quality management role in medical device industry preferred
  • Understanding of ISO requirements such as ISO 13485 preferred
  • Strong leadership skills, organizational abilities, problem solving techniques and interpersonal skills
  • Ability to work independently and manage multiple tasks simultaneously
  • Proficiency with Microsoft Office suite applications (Excel, Word, PowerPoint)
  • Experience with SAP software system preferred

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