Job Overview
We are seeking a proactive and detail-oriented Quality Executive to join our dynamic team. In this pivotal role, you will champion the integrity of our manufacturing processes by ensuring compliance with international quality standards and regulatory requirements. Your expertise will drive continuous improvement initiatives, uphold rigorous quality control measures, and foster a culture of excellence across all operational facets. If you thrive in a fast-paced environment and are passionate about delivering top-tier quality assurance, this is your opportunity to make a significant impact!
Duties
- Develop, implement, and maintain quality management systems aligned with ISO 9001, ISO 13485 (medical devices), and other relevant standards
- Conduct comprehensive quality audits to verify adherence to FDA regulations, HACCP protocols, CGMP guidelines, and internal policies
- Oversee quality control inspections throughout the manufacturing process to identify defects and ensure product consistency
- Lead root cause analysis for quality issues, facilitating corrective and preventive actions (CAPA) to eliminate recurring problems
- Collaborate with cross-functional teams on project management initiatives aimed at enhancing product quality and operational efficiency
- Monitor and analyze key quality metrics, preparing detailed reports for management review
- Facilitate training sessions on quality systems, regulatory compliance, and best practices for staff at all levels
Requirements
- Proven experience in manufacturing environments with a strong understanding of quality assurance and control processes
- Familiarity with ISO 13485, FDA regulations, HACCP, CGMP, ISO 9001 standards, and related compliance frameworks
- Demonstrated ability to conduct thorough quality audits and inspections effectively
- Strong analysis skills with the capacity to interpret data and identify improvement opportunities
- Excellent project management skills to coordinate multiple initiatives simultaneously
- Exceptional communication skills for training, reporting, and cross-departmental collaboration
- Certification in quality management or related fields is preferred but not mandatory
Join us as a Quality Executive and be at the forefront of ensuring our products meet the highest standards of safety, efficacy, and excellence. Your dedication will help shape our reputation as a leader in quality-driven manufacturing!
Pay: $50,000.00 - $60,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
Work Location: In person
