Quality Director

2 weeks ago


Marquand, Missouri, United States Cork Medical Full time
Job Title: Director of Quality and Regulatory Affairs

Cork Medical is seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to lead the company's quality management system and regulatory affairs functions.

The successful candidate will be responsible for driving all certifications and registrations, including ISO 13485:2016, MDSAP, 510K, and CE Mark. They will also manage quality procedures and supporting documentation, own the document management system, and provide recommendations for continuous improvement.

The Director of Quality and Regulatory Affairs will audit all quality procedures and supporting documentation, as well as all departments, to ensure the quality management system is being implemented appropriately. They will also manage and own the corrective and preventative action system, support 5S and process improvement, and oversee IQ, OQ, and PQ activities.

Additionally, the Director of Quality and Regulatory Affairs will manage regulatory updates, renewals, registrations, submissions, and 510Ks, as well as maintain and update the PDAC system. They will also be responsible for submission of all paperwork and/or documentation to government bodies or appropriate entities that regulate medical devices and/or the companies that Cork Medical currently engages with or will engage with in the sale and/or distribution of its products or labeled products.

The ideal candidate will have a Bachelor's degree or higher, degree or certification in quality systems or industry-relevant experience, knowledge and experience in technical writing and government submissions, project management experience, and knowledge of computer systems, document management software, or similar.

Key competencies for this role include time management, disciplined approach to process and procedure, self-driven with excellent follow-through, analytical skills, personal effectiveness in a team setting, effective communication, goal-oriented and metric-driven, and ethics with respect for others, inspiring trust, integrity in work, and upholding organizational values and culture.



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