Manager, Quality Assurance

$109,000 - $146,500/Yr

Inari Medical - Irvine, CA

Full-time - Manager

Irvine, CA

Miscellaneous Manufacturing

About the position

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.

Requirements

• Bachelor's degree in engineering or related technical field.
• Minimum 8 years of Quality Assurance experience.
• Minimum 1 year of supervisory experience.
• Computer skills including Word, Excel and Internet Experience.
• Detailed knowledge of 21 CFR 820, ISO 13485 and MDSAP regulations.
• Detail-oriented and organized.
• Excellent written and verbal communication skills, with the ability to interact effectively with internal and external stakeholders.
• A keen eye for detail to ensure accuracy in documentation and compliance with regulations.
• Ability to work effectively within a team, collaborating with various departments and personnel to achieve common goals.
• Able to prioritize and efficiently complete tasks with consistency and accuracy without supervision.
• Ability to analyze complex data, identify trends, and draw insights that inform strategic decisions.
• Proficient in critical thinking, problem-solving and analytical skills.
• Ability to teach and mentor.

Nice-to-haves

• Master's degree in engineering or related technical field.
• 10 years or more of Quality Assurance experience preferred.
• Prior work experience with medical device manufacturer preferred.
• 3 years or more of supervisory experience preferred.

Benefits

• Competitive health and wealth benefits for employees.
• Base pay range for this position is $109,000 - $146,500.