Manager, Quality Assurance

As Manager, Quality Assurance, your primary mission is to play a pivotal role in upholding the efficiency of the Quality Assurance department and ensuring unwavering compliance with our Quality Management System. This encompasses strict adherence to a comprehensive set of regulatory standards, including FDA GMP, ISO 13485, and MDSAP, among others. Your role is central to safeguarding the quality of our products and processes. By adhering to these standards, you help to minimize the risk of defects and enhance the quality and safety of our products. Your dedication is essential to ensure that we not only meet but consistently exceed the quality expectations of our customers. These efforts require constant focus on continuous improvement efforts including identifying procedural and process gaps. Beyond quality, your efforts contribute to the organization's compliance with an array of other pertinent regulatory requirements that pertain to our industry and the markets we serve. This regulatory adherence is pivotal in maintaining our reputation, fostering customer trust, and ensuring market access.

Responsibilities

• Serve as an experienced Quality Assurance representative that works with a cross-functional team (Manufacturing, R&D, Regulatory, Quality Engineering, etc.) with the ability to work self-sufficiently on assigned tasks.
• Develop, implement, and maintain quality standards, procedures and processes.
• Provide guidance and promotes a culture of continuous improvement.
• Resolve quality related issues between the QA department and other departments.
• Coordinate with engineers, technicians, and production or other department heads to ensure quality standards are maintained.
• Participate in cross-functional team to investigate quality issues / problems, perform risk assessments, implement resolutions.
• Monitor and trend quality data to identify potential quality issues and implement resolutions.
• Utilize quality measures and metrics to drive continuous improvement.
• Motivate, guide and lead teams to meet quality standards.
• Interpret and utilize Risk Management Files (Failure Modes and Effects Analysis).
• Ensure compliance with the Quality Management System and may own corrective or preventive actions (CAPA).
• Management of multiple projects and priorities without compromising quality or timelines.
• Adapt to new processes, technologies and market demands.
• Hire, train and evaluate Quality Assurance staff members.
• Communicate quality standards within the QA team and to other departments and stakeholders.
• Evaluate required changes to electronic Quality Management systems for continued compliance with external standards and regulations. Assist in the implementation of new Quality modules in the electronic Quality Management system.
• Collaborate with other members of the QA team to achieve departmental / company goals.
• Support audit activities including supporting external audits and addressing audit findings.
• Provide coaching and mentorship to team members.
• Perform other duties assigned as needed.

Qualifications

Preferred

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $109,000 - $146,500. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.

Inari Medical is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

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Disability accommodation for employment applicants

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Salary : $109,000 - $146,500