Quality Assurance (QA) Director – InGeneron

Primary job duties and responsibilities include but are not limited to:

  • Supervision and oversight of other Quality Assurance team members
  • Oversees InGeneron Quality Management System processes and ensures compliance
  • Reports Quality related questions, trends, and concerns to Executive Management
  • Works with production, product engineering, and contract manufacturers in the management of cGMP product design and development, manufacturing, packaging, labeling, and distribution to ensure the quality and safety of InGeneron product
  • Works with Regulatory professionals to ensure compliance of systems and products
  • Review and approval or rejection of documentation including, but not limited to:
    • Product and design specifications,
    • manufacturing batch/device history records,
    • test protocols
    • test records,
    • test results,
    • labeling,
    • deviations,
    • supplier qualification
  • Following applicable regulatory and statutory requirements for Investigations, CAPA, Material Review, NCMR, OOS, Complaints, Returns, Reporting and Recalls
  • Oversight of internal and external Auditing programs
  • Hosting of all notified body and regulatory audits and inspections
  • Oversight of Supplier Qualification program including review and approval of suppliers
  • Oversight of Training Program including assisting or conducting Annual Training
  • Oversight of Document Control and Quality Record systems
  • Work with Management to review and approve investigations including complaints and ensure material and product disposition is properly documented
  • Draft and approve standard operating procedures (SOPs) for QMS applications
  • Maintains a record of activities and follows applicable SOPs and good documentation practices
  • Comply with applicable regulatory, certification organization (e.g. Notified Bodies) and InGeneron Quality System requirements (i.e. Management Reviews).

Qualifications

Qualifications include:

  • Minimum of a Bachelor’s degree in Quality, sciences or related field
  • 10+ years of experience in medical device Quality Assurance
  • 7+ years of Quality System Auditing experience
  • Experience with ISO 13485, 21CFR820, MDD/MDR and ISO 14971
  • Formal training and/or certification in Quality System auditing
  • Self-starter, resourceful, flexible, responsive, detail oriented and possess a good work ethic
  • Must possess excellent written and verbal communication skills
  • Working knowledge of Microsoft Productivity Software (Word, Excel, Power Point, etc.)

Working Conditions

This position involves possible exposure to potentially hazardous chemicals and biohazardous materials.  Position may require transport of hazardous chemicals and materials, including human tissue and body fluids, such as blood. Handling of human specimens may result in possible blood borne pathogen exposure. Appropriate safety training and equipment will be provided by Company.  

May require periodic evening, holiday and weekend work, as necessary, to meet company deadlines. 

Interested persons should send their resume to contact@ingeneron.com .