Job Description

Job Summary

We are seeking an experienced and detail-oriented Quality Manager - Sales to oversee and enhance the quality assurance processes within our organization. This role involves ensuring compliance with industry standards such as ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP, and other quality systems. The ideal candidate will lead quality audits, manage quality control and inspection activities, and support manufacturing operations to uphold the highest standards of product quality and safety. This position offers an opportunity to contribute to a dynamic team dedicated to excellence in quality management and customer satisfaction.

Responsibilities

Develop, implement, and maintain comprehensive quality management systems aligned with ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP, and other relevant standards. Lead internal and external quality audits to ensure compliance with regulatory requirements and company policies. Oversee quality control and inspection processes across manufacturing operations to identify areas for improvement. Collaborate with manufacturing teams to ensure products meet specified quality standards through effective QA/QC practices. Manage non-conformance issues by investigating root causes and implementing corrective and preventive actions. Support project management initiatives related to quality improvements and new product launches. Analyze data trends to identify potential risks or areas for process enhancement. Provide training and guidance on quality systems, policies, and procedures to staff at all levels. Ensure adherence to regulatory requirements such as FDA regulations, HACCP, CGMP, and other applicable standards. Prepare documentation for regulatory submissions and facilitate external audits by authorities.

Requirements

Proven experience in Quality Management within manufacturing environments, especially in regulated industries such as medical devices or pharmaceuticals. Strong knowledge of ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP standards, and related quality systems. Demonstrated expertise in conducting quality audits, inspections, and implementing QA/QC procedures. Excellent analysis skills with the ability to interpret complex data sets and identify trends or issues. Project management skills with the ability to lead cross-functional teams on quality initiatives. Strong communication skills for effective training, reporting, and collaboration across departments. Relevant certifications in Quality Management or Regulatory Affairs are preferred. Bachelor's degree in Engineering, Quality Assurance, or a related field; advanced certifications are a plus. This role is integral to maintaining our commitment to delivering high-quality products that meet industry standards and customer expectations while fostering continuous improvement across all processes.
Job Type: Full-time

Pay: ?82,924.98 - ?99,866.64 per year

Work Location: In person