Extremity Care
Overview
The Director of Quality Systems at Extremity Care is responsible for the oversight of quality management system activities, including 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 drives best practices in quality engineering and collaborates cross-functionally across the organization.
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; ensure timely completion of investigations, root cause analysis, and effective implementation of corrective and 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 the 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 KPIs.
Oversee supplier management program to ensure qualification and maintenance of the approved supplier list.
Support documentation requests from regulatory affairs to support regulatory submissions (e.g., PMA supplements, 510(k) submissions).
Manage internal audit program and schedule to assess and maintain compliance of the quality management system with regulations/standards and internal policies.
Direct and lead internal, client, and regulatory agency audits to ensure compliance with regulatory requirements and internal policies.
Develop and maintain professional working relationships with customers, consultants, suppliers, and vendors.
Establish and execute continuing education strategy for the department.
Integrate shared leadership and foster collaboration across multi-disciplinary teams.
Maintain knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, and other relevant regulations and internal policies.
Manage direct reports; provide 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 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.
Ensure completion of assigned tasks within defined timeframes; maintain flexibility to work outside normal business hours as needed.
Perform other duties as assigned.
Skills
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 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.
Qualifications/Requirements
Bachelor’s degree in a biological science, engineering, or related field required.
Master’s degree in a biological science, engineering, or related field preferred.
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.
Details
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
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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; ensure timely completion of investigations, root cause analysis, and effective implementation of corrective and 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 the 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 KPIs.
Oversee supplier management program to ensure qualification and maintenance of the approved supplier list.
Support documentation requests from regulatory affairs to support regulatory submissions (e.g., PMA supplements, 510(k) submissions).
Manage internal audit program and schedule to assess and maintain compliance of the quality management system with regulations/standards and internal policies.
Direct and lead internal, client, and regulatory agency audits to ensure compliance with regulatory requirements and internal policies.
Develop and maintain professional working relationships with customers, consultants, suppliers, and vendors.
Establish and execute continuing education strategy for the department.
Integrate shared leadership and foster collaboration across multi-disciplinary teams.
Maintain knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, and other relevant regulations and internal policies.
Manage direct reports; provide 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 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.
Ensure completion of assigned tasks within defined timeframes; maintain flexibility to work outside normal business hours as needed.
Perform other duties as assigned.
Skills
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 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.
Qualifications/Requirements
Bachelor’s degree in a biological science, engineering, or related field required.
Master’s degree in a biological science, engineering, or related field preferred.
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.
Details
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
#J-18808-Ljbffr