What are the responsibilities and job description for the Quality Assurance Manager position at Venova Medical, Inc.?
The Quality Assurance Manager will assure compliance with medical device regulations and standards including the EU Medical Device Regulation (if applicable), ISO 13485 and FDA Quality System Regulation. Responsible for performing a wide variety of activities pertaining to quality assurance. Assure compliance with applicable regulatory requirements and company policies by conducting audits, training programs, managing and analyzing QA data, and maintaining the corrective and preventive action system.
COMPANY OVERVIEW
Venova Medical is at the forefront of innovation in the dialysis access space, committed to improving patient outcomes with groundbreaking medical technology. As we prepare to embark on critical stages of development for a new product requiring PMA approval, we are seeking a seasoned Quality Assurance Manager.
MAJOR DUTIES AND RESPONSIBILITIES
- Manage development of SOPs and overall quality system and assist other functional groups in the development of standard operating procedures.
- Develop or assist in the development of SOPs for the company quality system.
- Administer the internal quality audit program and perform internal audits of methods, processes, and procedures to ensure conformance to standards.
- Coordinate the entire process of initial release of documents and subsequent change process in accordance with established SOPs. Follows up on open Document Change Orders (DCOs) to ensure timely completion.
- Coordinate the corrective and preventive action system. Maintain database and provide trend reports.
- Develop and conduct training programs. Maintain training database and provide trend reports.
- Coordinate equipment calibration system. Schedule equipment calibration and maintain equipment database and files.
- Coordinate customer complaint system. Maintain complaint database and provide trend reports.
- Coordinate the supplier approval process and conduct supplier audits.
- Organizes and secures active and archived quality records to provide for efficient retrieval.
- Organize and maintain a library of purchased Standards.
- Analyze quality system performance data to prepare report(s) on Quality System effectiveness.
- Apply knowledge of good manufacturing practices (QSR) on a daily basis.
- Perform other duties in Quality Assurance and Regulatory Affairs as needed.
- Work in accordance with quality system procedures.
- Perform Quality Control inspections as requested.
PREFERRED QUALIFICATIONS
Education and / or Job Experience :
Skills, Abilities, and Requirements :
