Senior Quality Assurance

Overview:

Responsibilities include supporting the development, implementation and maintenance of the company’s Quality Management System and regulatory requirements and supporting product development and supply chain activities, in accordance with company policies and defined quality regulations and standards (e.g. ISO 13485, FDA 21CFR820, GMP, GDP for Medical Devices and cGMP for Drug/Medicinal or Biological Products in EU and USA). This includes, but is not limited to: writing and approving quality procedures and related documentation, performing internal and external quality audits, handling deviations, document control and archiving, training and batch record reviews and participation in product development teams.  This will be a full-time, on-site position out of our Sandy Springs office with a move to Alpharetta in July 2026.

Key Responsibilities: 

• QA responsibilities
• • Write quality procedures and related documentation.
  • Review and approve quality procedures and related documentation, including production-related documentation and verification of study data.
  • Support maintenance of a document control system, as required, to ensure revision control, release, distribution, accountability, and traceability of quality documentation, including external standards, and quality records, as well as providing support where required, to ensure that appropriate functions are kept up-to-date regarding activation of new or revised quality documentation.
  • Providing support as necessary to maintain the training registration system to ensure training plans are kept up to date.
  • Plan, perform, and report internal and external (supplier) audits.
  • Provide support as required to the supplier/subcontractor qualification system, including the review and approval of relevant quality documentation.
  • Perform staff training on QA topics, including production-related activities and quality / regulatory standards.
  • Set up and maintain QA databases on Quality Indicators, in order to ensure that relevant information is up to date and accessible to relevant functions.
  • Support maintenance of system for registration and archiving of documentation (internal or external), in order to ensure safe storage, traceability and easy retrieval for the defined archive period.
  • Support coordination of change control systems.
  • Maintain overview of quality indicators that are appointed, including DEVs, customer complaints, and CPAs (including follow-up), and regularly report status to the QA Director, in order to ensure the timely identification of product problems, systematic problems (trends), and other areas where improvement is needed.
  • Knowledge of relevant quality systems and regulatory requirements. Keep up to date on QA -related topics and share information with colleagues.
  • Identify needs for changes in the Quality Management System. Detect problems and suggest and/or implement improvements.
  • Participate in project teams such as product development and risk management.
  • Coordinate quality-related projects, as required.
  • Communication with external parties (e.g., customers).
  • Maintain compliance of the company’s products with the regulations of the relevant regulatory authorities (e.g., Notified Body, IGZ, FDA, EMA).
  • Support maintenance of quality & regulatory standards and guidance documents, as required, including review of eventual gaps introduced by new or updated standards.
  • Providing support in the product approval process, e.g., CE marking, 510k.
  • Coordinating and participating in external audits and inspections by regulatory authorities and customers.
• Safety/Organizational/Productivity:
  • Know, understand and adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents and radioactive hazards.
  • Participate in the introduction and evaluation of new procedures, supplies, and equipment.
  • Ensure proper training of colleagues, students, etc.
  • Use resources (equipment, disposables, time) in a responsible, cost-effective manner.

Qualifications: 

Education

• Bachelor's degree in a Life Sciences discipline (e.g. Dutch HLO) or technical discipline (e.g. Dutch HBO in Chemistry or Physics) or equivalent.

Experience

• Must be able to work well independently, as well as being able to work cooperatively in a team of professionals.
• Sound working knowledge of ISO 13485 or ISO9001, cGMP (FDA 21CFR820- QSR) or pharma GxP requirements and relevant QA experience relating to (cleanroom) pro