Medical Devices Quality Assurance Lead
hace 1 semana
North American Medical Corporation, a world-class manufacturer of spinal orthopedic devices, is seeking a seasoned Quality Assurance professional to lead our team.
About the Role
We are offering a competitive salary of $120,000 - $150,000 per annum, plus benefits, for an experienced QA professional to oversee our quality management systems and ensure compliance with FDA regulations.
Key Responsibilities:
- Quality Management System Oversight: Ensure adherence to Good Manufacturing Practices (GMP) and ISO 13485:2016 standards.
- Team Leadership: Manage a team of 6-10 people, providing guidance and mentorship to ensure high-quality work.
- Process Improvement: Identify areas for improvement and implement changes to enhance operational efficiency and customer satisfaction.
- Complaint Handling and CAPA: Lead root cause analysis and implement corrective actions to resolve issues.
- Regulatory Compliance: Ensure ongoing compliance with FDA regulations and maintain up-to-date knowledge of industry developments.
- Audits and Inspections: Prepare for and participate in internal audits and external inspections, ensuring seamless execution.
Requirements:
- Experience: At least 7 years in a similar role within Industrial and Medical device sectors.
- FDA Regulatory Knowledge: Working understanding of FDA regulations and guidelines.
- Leadership Skills: Proven ability to build and manage high-performing teams.
- Analytical Skills: Strong analytical skills, comfortable working with numerical data and technical writing.
- Travel: Willingness to travel approximately once per month.
Benefits:
- Competitive Salary: $120,000 - $150,000 per annum.
- Benefits Package: Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
- Career Growth Opportunities: Exciting career growth opportunities in a growing business.
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