Quality Manager - ISO13485 experience with audits a must!

NOTE: MUST HAVE EXPERIENCE WITH  ISO 13485

The QA Ops Manager will oversee and enhance the quality control processes on the production floor. The ideal candidate will be responsible for implementing and maintaining quality assurance protocols, leading a team of quality control professionals, and driving continuous improvement initiatives. 

Duties and responsibilities

• Quality Assurance Management: Develop, implement, and maintain quality assurance policies and procedures to ensure compliance with industry standards and regulatory requirements.
• Production Floor Oversight: Monitor and assess production processes to identify and address quality issues in real-time, ensuring that all products meet or exceed our high-quality standards.
• Team Leadership: Lead, mentor, and manage a team of quality control inspectors and technicians. Provide training and support to ensure high performance and adherence to quality standards.
• Continuous Improvement: Identify areas for improvement in quality control processes and work with cross-functional teams to implement corrective actions and process enhancements.
• Compliance and Documentation: Ensure that all quality control documentation is accurately maintained and compliant with internal and external auditing requirements.
• Customer and Vendor Relations: Address and resolve any quality-related concerns from customers and vendors, working to enhance satisfaction and maintain strong relationships.
• Reporting and Analysis: Prepare and present detailed quality reports to management, analyzing trends and metrics to drive decision-making and strategic planning.

Qualifications

• Bachelor’s degree in Quality Management, Engineering, Chemistry, or a related field. A Master’s degree or relevant certifications (e.g., Six Sigma, ASQ) is a plus.
• Proven experience (5 years) in quality management within a manufacturing environment, preferably in the glove or related industry.
• Strong knowledge of quality assurance methodologies, regulatory requirements, and industry standards.
• Excellent leadership and team management skills, with a track record of driving performance improvements.
• Strong analytical skills with the ability to interpret complex data and implement effective solutions.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively with all levels of the organization.
• Strong working knowledge of ISO 13485, 21 CFR Part 820, and GMP regulations.
• Hands on experience with CAPA, nonconformance investigations, internal audits, supplier quality and regulatory inspections.