What are the responsibilities and job description for the QA Manager position at Shummi US LLC?
Come join us to take charge of our Quality Management System and elevate product standards in a dynamic, growth-oriented environment!
The Quality Manager will lead the quality assurance team and ensure that all products meet the highest quality standards. This role involves developing, implementing, and maintaining quality assurance processes and procedures, collaborating with various departments to support operational activities, and adhering to Quality Management System guidelines.
Essential Functions:
- The Quality Manager will lead our Quality Department and work cross-functionally with the rest of the company.
- This role will manage and maintain the ISO-9001, GMP, ISO-13485 QMS, lead annual audits, and manage the Quality team.
- Will support the development, maintenance, and execution of our quality control standards, policies, and procedures in line with industry best practices and regulatory requirements by 21 CFR
Part 820.180 & 820.198 / Quality System & GMP Requirements for Class 1 Exempt Medical Devices
- Will lead, mentor, and manage a team of quality control engineers, technicians, and inspectors * Collaborate with Operations, Advanced Manufacturing, Sourcing, Sales, and engineering to identify and address quality-related issues and develop effective solutions.
- Establish and monitor key performance indicators (KPIs) to measure and improve product/service quality and operational efficiency.
- Conduct thorough inspections and audits of products/services at various stages to identify defects, deviations, or non-conformities.
- Analyze data and trends to identify areas for improvement and recommend corrective actions.
- Participate in the development and execution of training programs to ensure that all team members are well-versed in quality control protocols and standards.
- Communicate and collaborate with suppliers and vendors to ensure the quality of incoming materials and components.
- Prepare and present quality control reports and metrics to senior management.
Qualifications
Required/Preferred Experience:
- Bachelor's degree in Engineering/relevant degree
- Work experience GMP / ISO 13485 audit experience.
- Proven experience in quality control, with a minimum of 5 years in a managerial or supervisory role.
- Strong knowledge of quality control methodologies, standards, and regulatory requirements.
- Excellent leadership and team management skills, with the ability to motivate and guide a diverse team.
- Effective communication and interpersonal skills, with the ability to collaborate across departments and present findings to senior management.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
