Quality Assurance Specialist

Overview
Join our dynamic team as a Quality Assurance (QA) Specialist and play a vital role in ensuring the highest standards of product quality and safety. In this energetic position, you will be at the forefront of implementing and maintaining robust quality systems, conducting comprehensive audits, and ensuring compliance with industry regulations. Your dedication will help us deliver safe, reliable, and top-quality products to our customers. This paid position offers an exciting opportunity to develop your expertise in quality management within a fast-paced manufacturing environment.

Responsibilities

• Develop, implement, and maintain quality assurance protocols aligned with ISO 13485, FDA regulations, ISO 9001, HACCP, CGMP, and other relevant standards.
• Conduct regular quality audits across manufacturing processes to identify areas for improvement and ensure compliance with regulatory requirements.
• Perform detailed quality inspections and control checks on raw materials, in-process components, and finished products to verify adherence to specifications.
• Lead root cause analysis investigations for quality issues and coordinate corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams to enhance quality systems, streamline processes, and support continuous improvement initiatives.
• Prepare detailed reports on audit findings, inspection results, and compliance status for management review.
• Support training programs to promote a culture of quality awareness throughout the organization.

Requirements

• Proven experience in quality assurance within a manufacturing or production setting; familiarity with medical device or pharmaceutical industries is highly desirable.
• Strong knowledge of ISO 13485, FDA regulations, HACCP, CGMP, ISO 9001 standards, and quality management principles.
• Demonstrated ability to conduct thorough quality audits and inspections with attention to detail.
• Excellent analysis skills for identifying issues and implementing effective solutions.
• Experience with quality control tools such as statistical analysis, trend analysis, and documentation management.
• Effective project management skills to coordinate multiple initiatives simultaneously.
• Strong communication skills to clearly document findings and collaborate across teams. Join us in our mission to uphold the highest standards of product excellence! This role offers an engaging environment where your expertise directly impacts product safety and customer satisfaction. We are committed to supporting your professional growth through ongoing training in quality systems and industry regulations—empowering you to become a key driver of our quality excellence journey.

Work Location: In person