Interim Director of Quality
North Palm Beach, FL – onsite presence is required (2 days per week remote OK)
Hours per week:
Our Medical Device client is currently seeking a seasoned Director of Quality for a 12 month assignment to work within a start-up environment to augment spinal technology. This ideal candidate would have prior experience in bringing a product through the EUMDR certification and understands what notified bodies are looking for. The EUMDR procedures have been put together and this resource would be assisting with ensuring that the results generated and documented pertaining to the product are aligned with what regulatory bodies will be looking for to obtain ultimate approval. This is a hands-on position at the director-level where lots of hats will be worn to help in areas as needed. This is a hands-on position at the director-level where lots of hats will be worn to help in areas as needed; the selected resource will essentially be the Quality Representative of the company.
Candidates with experience relating to Class III implantable devices are highly preferred, however expertise in working within a small start-up environment, ISO standards and bringing a class II-III medical device through the EUMDR certification is required. Experience with Arena PLM or a comparable eQMS is required.
FL: Director of Quality (233803)