Quality Engineer

Check out the role overview below If you are confident you have got the right skills and experience, apply today.

We are seeking a proactive and detail-oriented Quality Engineer to join our dynamic team. In this role, you will be instrumental in ensuring our manufacturing processes and products meet the highest quality standards by developing, implementing, and maintaining robust quality systems. Your expertise will help drive continuous improvement initiatives, uphold compliance with industry regulations, and foster a culture of quality excellence across all operations. This position offers an exciting opportunity to contribute to innovative products while ensuring safety, reliability, and customer satisfaction.

• Duties
• Develop, implement, and maintain quality management systems aligned with ISO 13485 (medical devices), ISO 9001 (quality management), and other relevant standards to ensure compliance across all manufacturing processes.
• Conduct comprehensive quality audits to identify areas for improvement, verify adherence to regulatory requirements such as FDA regulations, HACCP (Hazard Analysis Critical Control Point), and CGMP (Current Good Manufacturing Practices).
• Perform detailed quality inspections and control checks throughout the production cycle to detect defects, ensure product consistency, and uphold quality assurance protocols.
• Lead root cause analysis investigations for non-conformities or product failures, utilizing strong analysis skills to recommend corrective and preventive actions.
• Collaborate with cross-functional teams—including manufacturing, engineering, and project management—to develop quality plans that enhance process efficiency and product reliability.
• Oversee documentation of quality procedures, audit reports, inspection records, and compliance documentation to support regulatory submissions and internal reviews.
• Facilitate internal and external quality audits, ensuring readiness for certification processes and maintaining accreditation standards.
• Support training initiatives to promote awareness of quality systems, regulatory requirements, and best practices among staff members.
• Requirements
• Bachelor’s degree in Engineering, Quality Management, or a related field; advanced certifications in quality assurance or project management are a plus.
• Proven experience working within manufacturing environments with a strong understanding of quality control (QC), quality assurance (QA), and quality systems management.
• In-depth knowledge of ISO 13485, ISO 9001 standards, FDA regulations, HACCP principles, and CGMP guidelines applicable to regulated industries.
• Demonstrated ability to perform thorough quality audits and inspections with meticulous attention to detail.
• Strong analysis skills for identifying root causes of issues and implementing effective corrective actions.
• Excellent communication skills for documenting findings clearly and collaborating effectively across teams.
• Familiarity with QA / QC tools such as statistical process control (SPC), failure mode effects analysis (FMEA), and control charts is desirable.
• Project management skills to coordinate multiple initiatives simultaneously while maintaining high standards of quality. Join us as a Quality Engineer if you’re passionate about elevating product excellence through rigorous standards, innovative problem-solving, and dedicated teamwork! Your expertise will help shape the future of our products while ensuring they meet all safety and regulatory benchmarks—making a real difference in the lives of our customers worldwide.

Job Type : Full-time

Pay : $75,000.00 - $90,000.00 per year

Benefits :
• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location : In person