Site Quality Assurance and Regulatory Affairs Delegate

May 22, 2024


The Manager of QA and RA site delegate provides leadership across all departments at LISA Laser to ensure quality objectives are met while maintaining global regulatory compliance. Direct areas of responsibility include quality assurance, quality control, supplier quality, document control, quality training and regulatory compliance.

The Manager reports to the Global Director of RA & QA at Omni-Guide Holdings, Inc.

Essential Functions:

  1. Provide QA/RA leadership across all departments, giving input to senior management, for product and process improvements.
  2. May act as the Local Management Representative for the Quality Management System.
  3. Train site employees in compliance with quality system standards such as 21 CFR 820 and ISO 13485.
  4. Participate with the management team in developing and implementing relevant Quality Systems strategic plans, maintaining key performance indicators (Site KPIs).
  5. Ensures site is always regulatory inspection ready (EU, FDA, Notified Body, international regulatory bodies, customers, and other QA/RA regulatory entities).
  6. Plans, coordinates, and direct Quality Systems strategies for new products in coordination with the Global Director of RA & QA.
  7. Manages site quality control, quality assurance, supplier quality, calibration, complaint handling and document control requirements.
  8. Conducts investigations and implements corrective actions to resolve complaints and to address compliance gaps.
  9. Collaborates with Omni-Guide Global Director of RA/QA and implements at LISA, quality system management strategies, QMS unification plans, cross-departmental strategies, systems, and timelines.
  10. Facilitates strong site culture of quality.
  11. All other duties as assigned by the Global Director RA/QA without restriction, including reassignment to a different job at any time.

Essential knowledge:

  1. Extensive knowledge of ISO 13485, QSR and CE marking.
  2. Ten plus years of regulatory compliance/quality systems/regulatory submissions experience in Class 1 and Class II medical devices required.
  3. Experience with Medical/Surgical Lasers: s preferred. other applicable experience is a plus.
  4. Five to seven years’ experience as a manager.
  5. Demonstrated effective leadership ability and experience.
  6. Demonstrated ability to effectively manage multiple priorities in a fast-paced deadline-driven environment.
  7. Strong organizational, written, and verbal communication skills in German and English.

Education requirements:

  1. Bachelor’s degree or 10+ years of experience
  2. Must be able to use basic office equipment, computer, printer, copier, phone, etc…
  3. Must be capable of communicating with stakeholders at all corporate levels.

Work Location: Albert-Einstein-Str. 4, 37191 Katlenburg- Lindau, Germany
Department: Quality and Regulatory
Type of Position: On site, full-time