Overview
Quality Systems Specialist Jobs in El Paso, Texas, USA at GCX
Job Purpose:
Provide Quality Systems support to ensure the successful development and continual improvement of GCX Healthcare Solutions Quality Management System. This individual will be expected to apply his/her knowledge of Quality Systems principles and regulatory requirements to positively collaborate in maintenance and continuous improvement of the QMS.
Responsibilities
Lead the development, maintenance, and continuous improvement of the Global Quality Management System (QMS) framework, including CAPA (Corrective and Preventive Action), Change Control, Complaint Management and Internal Audits.
Independently conduct internal quality audits, utilizing strong analytical skills to identify areas for improvement and leading corrective action activities to address identified non-conformances. This position will also be expected to host external audits.
Become a data-driven quality champion, analyzing quality system data to identify trends and proactively recommending and implementing QMS improvement initiatives.
Maintain and update complex quality system documentation, ensuring accuracy, completeness, and adherence to all relevant regulations and industry standards.
Champion quality excellence by supporting the development and implementation of effective quality training programs across the organization.
Take ownership of managing CAPA and customer complaints, driving efficient resolution, identifying root causes, and implementing preventive actions to prevent recurrence.
Lead risk management activities within assigned areas, proactively identifying, assessing, and mitigating potential risks to the QMS.
Manage and actively participate in cross-functional projects related to quality systems, fostering collaboration and driving continuous improvement.
Administer and improve an effective Document Control program.
Travel requirements: 25%
Job Qualifications/Requirements:
Bachelor’s degree (B.S.) required.
Minimum 2 years of experience in a quality systems role, preferably within the medical device industry.
Prior experience working in a regulated industry (FDA, GMP) preferred.
13485 Lead Auditor / Green Belt certification preferred.
Understanding and proven experience applying relevant quality standards (e.g., ISO 13485, FDA QSR).
Excellent analytical and problem-solving skills with a demonstrated ability to identify root causes and implement effective solutions.
Outstanding communication and interpersonal skills, with the ability to effectively train, mentor, and collaborate with colleagues at all levels.
Proven ability to work independently, manage multiple priorities, and meet deadlines.
Proficient in Microsoft Office Suite and familiar with quality system management software.
Prior experience working in medical device industry and with product submissions to regulated bodies (e.g., FDA) preferred.
Project Management skills preferred.
Commitment to excellence and high standards.
Excellent written and oral communication skills preferred.
Strong organizational, problem-solving, and analytical skills.
Ability to manage priorities and workflow.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Acute attention to detail.
Demonstrated ability to plan and organize projects.
Ability to work independently and as a member of various teams.
Proven ability to manage multiple projects and meet deadlines.
Ability to develop clear, concise, and timely oral and written reports.
Accurately complete detailed forms and reports.
Regulatory experience preferred.
#J-18808-Ljbffr
Title: Quality Systems Specialist
Company: GCX
Location: El Paso, Texas, USA
Category: Quality Assurance – QA/QC, Healthcare
