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Job Title Quality Systems Specialist
$58k-74k (estimate)
Full Time
1 Week Ago
GCX Healthcare Solutions is Hiring a Job Title Quality Systems Specialist Near El Paso, TX
Provide Quality Systems support to ensure the successful development and continual improvement of GCX Healthcare SolutionsQuality 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.
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.
Job Summary
JOB TYPE
Full Time
SALARY
$58k-74k (estimate)
POST DATE
05/05/2024
EXPIRATION DATE
07/03/2024
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