Quality Control Manager

Job Description

Job Description

Job Summary
We are seeking a dedicated and detail-oriented Quality Control Manager to oversee our quality assurance processes and ensure compliance with industry standards. The ideal candidate will have a strong background in QA/QC methodologies, project management, and familiarity with FDA regulations. This role is crucial for maintaining the integrity of our products and ensuring that they meet both internal and external quality standards.

Responsibilities

• Develop, implement, and maintain quality assurance protocols to ensure compliance with ISO 13485 and ISO 9001 standards.
• Conduct regular quality audits and inspections to identify areas for improvement and ensure adherence to established procedures.
• Analyze data from quality inspections to identify trends, issues, and opportunities for enhancement in production processes.
• Collaborate with cross-functional teams to facilitate effective project management related to quality initiatives.
• Provide training and support to staff on quality assurance practices and FDA regulations.
• Oversee the fabrication process to ensure that all products meet specified quality criteria before release.
• Prepare detailed reports on quality metrics for management review and decision-making.

Requirements

• Bachelor’s degree in a relevant field or equivalent experience in Quality Assurance/Quality Control.
• Proven experience in QA/QC roles, with a strong understanding of FDA regulations and ISO standards (ISO 13485, ISO 9001).
• Strong analytical skills with the ability to interpret complex data sets related to quality inspections.
• Excellent project management skills, demonstrating the ability to lead initiatives effectively.
• Familiarity with conducting quality audits and implementing corrective actions as necessary.
• Strong communication skills, both verbal and written, with an emphasis on collaboration across departments.
• Detail-oriented mindset with a commitment to maintaining high-quality standards in all aspects of work.

We invite qualified candidates who are passionate about quality assurance to apply for this pivotal role within our organization.