This position is responsible for the establishment and ongoing management of the company’s Quality Plan and Quality Policy, as well as all associated documentation, procedures, policies and processes. He or she shall ensure FDA and ISO 13485 Compliance (as well as all updates), perform QA and vendor audits, prepare and submit 510(K) applications and CE Mark related Tech Files and act as the FDA/ISO/CE Certificate audit liaison for the company.
Individual oversees the Company’s Quality Plan, develops processes, develops and oversees equipment and process validations, SOP’s, and ensures compliance to appropriate regulations and guidelines. He or she will manage all CAPA’s, customer complaints, complaint trend analyses and other measurements important to the company’s ability to produce consistent high quality, safe and efficacious product.
The individual will also be responsible for all global regulatory submissions and manage the employees who are within the Regulatory Affairs and Quality Assurance Dept. This is a roll-up-the-sleeves position that reports to the CEO and represents a key role for the organization.
The individual will have at least 7 years of experience in these areas and be able to work independently, as well as part of a Team. This position is located in Hudson, NC.
Internal Number: RAQADIR
About Adhezion Biomedical, LLC
Adhezion Biomedical, LLC is a privately-held medical device company engaged in the development, manufacturing and commercialization of cyanoacrylate-based adhesive and infection prevention products.