Get in on the ground floor as part of an exciting opportunity with Perimetrics, LLC.- a young, innovative, well-funded dental device start-up in the diagnostic devices field.
We are looking for a Quality Assurance Leader who is ready to take the next step in their professional career. This person will have responsibility for developing the quality system and regulatory landscape for Perimetrics as a key organizational leader of our new enterprise.
Duties and Responsibilities:
Responsible for developing and executing regulatory and quality plans in support of corporate goals and objectives.
You will provide recommendations on all aspects of company business that involve quality system compliance and ensure regulatory compliance throughout the organization. Develop and manage the FDA-QSR and ISO quality system requirements.
Designated Management Representative (deputy) per FDA-QSR and ISO quality system requirements; specifically:
Directs the development and maintenance of the quality assurance system and processes.
Ensures processes needed for the quality management system are established, implemented and maintained.
Reports to top management on the performance of the quality management system and any need for improvement.
Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.
Responsible for coordinating Design Control activities as they relate to FDA-QSR and ISO.
Responsible for researching and applying for and or maintaining international regulatory certification for Perimetrics, LLC.
Active in external audits and inspections.
Responsible for wearing many "hats" in a very small company environment where helping coordinate functions such as Design Control, technical report writing, and supplier qualification is needed.
Desired Training and Experience:
5+ years experience with Quality Assurance and Regulatory Affairs activities.
5+ years experience with medical devices.
In-depth knowledge of the FDA, CE and ISO regulatory/quality processes and personal experience in working directly with regulatory agencies (e.g., 510Ks, CE, Notified Bodies, etc.).
Experience with FDA, QSR and ISO quality systems requirements.
Excellent interpersonal, written and verbal communication skills.
The ability to present information to executive and board level professionals.
Experience with packaging and labeling requirements.
Strong computer skills for developing and maintaining an electronic Quality System.
Additional Salary Information: Performance Based Bonus;
Benefits to include 100% coverage for employees with 0 deductible options, PPO Dental, Vision, and many more.