Quality Management Systems (Qms) Manager / Regulatory Affairs Specialist

The QMS Manager manages core processes of the Quality Management System (QMS) in accordance with international standards, regulatory requirements, customer requirements, and BioGX?s standard operating procedures herein referred to as ?QMS requirements?. Uses discretion and independent judgment to fulfill essential duties & responsibilities outlined below.

Essential Duties and Responsibilities:
Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
Responsible for assigned quality related activities within the organization, including but not limited to the maintenance of BioGX?s QMS, corrective action, preventive action, and process performance monitoring activities required to maintain compliance to QMS requirements.

• Manages document control for QMS related documents and procedure development processes in accordance with QMS requirements.
• Manages corrective and preventive action processes in accordance with QMS requirements including follow-ups through completion and effectiveness checks
• Manages equipment management processes to include preventive maintenance and calibration activities in accordance with QMS requirements.
• Performs compliance monitoring activities to include atmospheric monitoring, material evaluation and acceptance monitoring, product evaluation and acceptance monitoring, receipt and dispositioning of nonconforming material/product monitoring, equipment qualification monitoring, material and product traceability monitoring, material and product identification monitoring, risk mitigation monitoring, supplier performance monitoring, product realization monitoring, record control including good documentation practices monitoring and other BioGX process monitoring as needed.
• Manages the reporting of QMS performance objectives and supporting activities. Participates in the regular review of quality objectives and identifies the need for corrective and preventive action.
• Manages QMS auditing processes and supporting activities.
• Monitors and reports on key performance indicators with regards to quality processes to identify the need for corrective and preventive action.
• Ensures that processes needed for the Quality Management system (QMS) are implemented and maintained in accordance with requirements. Develops and implements strategies to support/maintain compliance to QMS requirements.
• Alternative interface with FDA, Notified Bodies, and Alabama State Department of Health in the event of Company inspections. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities and partners.
• Assists with risk management processes and supporting activities.
• Promotes the awareness of customer requirements. Echoes the importance of meeting customer, statutory and regulatory requirements.
• Brings together staff of different disciplines and drives the group to plan, formulate and agree on comprehensive quality procedures. Communicates with other company personnel to coordinate operations and activities.
• Other duties as assigned.

Supervisory Responsibilities:
Directs and manages subordinate employees working within the department of Quality &
Regulatory Affairs as assigned.

Qualifications: To perform this job successfully, an individual must be able to perform each
essential duty satisfactorily. The requirements listed below are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be made to enable individuals
with disabilities to perform the essential functions.

• Excellent verbal and written communication skills.
• Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
• Working knowledge of FDA?s QSR/cGMP, international standards, and Quality Assurance systems.
• Medical Device industry experience.
• Strong computer skills having advanced knowledge and experience with current word processing, spreadsheet, graphical, and file management software.
• Proficient in typing and keyboard topology.
• Extremely detail-oriented with strong organizational skills and high quality standards

Education and Experience:
Bachelor of Science Degree from a four-year accredited college or university; or five or more years related experience and/or training.