Director of Quality Systems

Extremity Care•San Antonio, TX

About The Position

The Director of Quality Systems is responsible for oversight of quality management system activities. Specifically, this encompasses quality oversight in design control, design verification/validation, design history files, and risk assessment to ensure compliance with established standard operating procedures, FDA regulations, AATB Standards, ISO standards and other applicable regulations and industry standards. This role is responsible for driving best practices in quality engineering and collaborating cross functionally across the organization.

Requirements

Knowledge of FDA’s Quality System Regulations, and the Canadian Medical Device Regulations
Ability to manage multiple complex problems simultaneously
Ability to be flexible in changing daily workload priorities as directed
Ability to coordinate and synchronize multiple projects
Ability to conduct a significant amount of planning activities for self and others
Ability to take initiative and make decisions within company/departmental guidelines
Ability to thrive under challenging deadlines and in an energetic environment
Ability to work independently and in a team environment
Excellent attention to detail and organization
Excellent written and verbal communication
Highest level of ethics and integrity
Ability to lead and motivate the right behaviors
Strong technical writing
Effective project management
Proficiency in Microsoft Office
Bachelor’s degree in a biological science, engineering, or related field required
At least 8-10 years of experience in an FDA regulated environment for HCT/Ps, medical devices, and/or pharmaceutical manufacturing, with at least 3 years in a management role for quality assurance, regulatory affairs, and/or engineering
Clearance of favorable background investigation required

Nice To Haves

Master’s degree in a biological science, engineering, or related field preferred

Responsibilities

Develop, implement, and maintain standardized processes in the Quality Management System to ensure compliance with relevant standards and regulations
Oversee management, review, and approval of Quality Event investigations from initiation to closure for complaints, deviations, non-conformances, CAPAs, and SCARs to ensure timely completion, and ensure timely completion of associated investigations, appropriate root cause analysis, and effective implementation of corrective/preventive actions
Oversee, lead, and manage quality system related meetings including management review
Lead and/or support risk management initiatives by identifying, addressing, and escalating risks/issues as necessary
Lead and support continuous improvement initiatives to enhance quality system processes
Oversee and manage and use of quality system software(s)
Lead and provide organizational training and guidance on quality standards, processes, procedures, and corrective/preventive actions
Oversee management and coordination of training requirements/assignments
Manage the quality data collection and reporting processes, including tracking and analyzing key performance indicators (KPIs)
Oversee supplier management program to ensure appropriate qualification and maintenance of the approved supplier list
Support documentation requests from regulatory affairs department to support regulatory submissions (e.g. PMA supplements, 510(k) submissions)
Manage internal audit program and schedule to assess and maintain compliance of quality management system with regulations/standards, and internal organizational policies and standard operating procedures
Direct and lead internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and standard operating procedures
Develop and maintain professional working relationships with current and potential customers, consultants, suppliers, and vendors
Establish and execute continuing education strategy for department
Integrate shared leadership and foster collaboration across multi-disciplinary teams
Maintains company compliance and a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
Manage direct reports
Provide constructive feedback and guidance to develop leadership in direct reports and department management
Establish and monitor objective annual goals for direct reports
Conduct performance reviews and establish performance improvement plans as needed
Recruit, interview, and select personnel for hire
Travel domestically up to 25% to attend offsite meetings, conferences, and support business initiatives
Maintain acceptable attendance and punctuality for scheduled work hours and meetings
Ensure completion of assigned tasks and responsibilities within defined timeframes
Maintain flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
Perform other duties as assigned