Director of Quality and Regulatory Affairs

4 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 Director of Quality and Regulatory Affairs to join our team. The successful candidate will be responsible for owning, auditing, and driving improvements within our Quality Management System (QMS).

Main Responsibilities:
  • Drive all Cork Medical certifications & registrations, including ISO 13485:2016, MDSAP, and 510K.
  • Manage all Quality Procedures & supporting documentation, working closely with department managers.
  • Own the Document Management System (DMS) and provide recommendations for continuous improvement.
  • Audit all Quality Procedures & supporting documentation, as per schedule, to ensure policies & procedures are followed.
  • Audit all departments to ensure the QMS is being implemented appropriately.
  • Manage and Own the Corrective & Preventative Action (CAPA) System.
  • Support CMP Management for successful implementation and adherence to departmental procedures.
  • Oversee all IQ, OQ, PQ activities at Cork Medical.
  • Support 5S and Process Improvement within the organization.
  • Support ERP/MRP/QMS software implementation.
Regulatory Responsibilities:
  • Manage Regulatory Updates, Renewals, Registrations, Submissions, 510K's or other as required.
  • Manage Medical Device Reporting to Regulatory Bodies.
  • Maintain / Update PDAC System.
  • Manage Device Labeling Requirements or Policies.
  • Responsible for submission of all paperwork and/or documentation to government bodies or appropriate entities (domestic or foreign) that regulate medical devices and / or the different companies that Cork Medical currently engages with, or will engage with, in the sale and / or distribution of its products or labeled products.
Requirements:
  • Bachelor's Degree.
  • 10+ years of Quality and Regulatory Experience within the healthcare field.
  • Experience with managing a team.
  • Degree or Certification in Quality Systems or Industry Relevant Experience.
  • Project Management Experience Preferred.
Key Competencies:
  • Time Management.
  • Disciplined to Process and Procedure.
  • Self-Driven with Excellent Follow Through.
  • Analytical.
  • Personal Effectiveness in a Team Setting.
  • Effective Communicator.
  • Goal Oriented and Metric Driven.
  • Ethics - Respects Others, Inspires Trust of Others, Integrity in his/her Work, Upholds Organizational Values & Culture.
Working Conditions:

The physical demands & work environment factors described below are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Employees may be regularly required to use hands to handle or feel, reach with hands and arms, and talk or hear. Employees may be frequently required to sit or stand for periods of time. He/she may be required to push, pull, or lift objects up to 50 lbs. He/she may be required to use a ladder. Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus. Working Conditions - Includes Offices, Manufacturing Areas, Engineering Lab, Clean Room, and Warehouse Environment

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