Quality Manager

Responsibilities

• Understand customer needs and requirements to develop effective quality control processes
• Devise and review specifications for products or processes
• Set requirements for raw material or intermediate products for suppliers and monitor their compliance
• Ensure adherence to health and safety guidelines as well as legal obligations
• Supervise inspectors, technicians and other staff and provide guidance and feedback
• Oversee all product development procedures to identify deviations from quality standards
• Inspect final output and compare properties to requirements
• Approve the right products or reject defectives
• Keep accurate documentation and perform statistical analysis
• Solicit feedback from customers to assess whether their requirements are met
• Submit detailed reports to appropriate executives
• Implement, manage, and improve the company's quality management system, with a primary focus on IVD products and equipment
• Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA)
• Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department
• Manage the documentation of the company's quality management system, ensuring compliance with relevant standards and regulations
• Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards
• Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed
• Update company documents in accordance with new or revised quality standards, laws, and regulations
• Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements

Requirements

• Minimum Bachelor's degree in Science or related field
• ISO 13485:2016 lead auditor certification preferred
• Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards
• Strong understanding of quality management principles and practices in the medical device industry
• Excellent communication and interpersonal skills
• Ability to work collaboratively in a team environment
• Demonstrated problem-solving and analytical skills
• Attention to detail and strong organizational skills

Benefits

• Medical Insurance Plan
• Retailer Plan
• Paid Time Off
• Training & Development

Pay

$100,000 - $130,000

Schedule

Onsite