Quality Manager, Manufacturing

**Please note that this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. 

As a Quality Manager, you will play a pivotal role in ensuring the highest standards of quality across our operations. You will be responsible for planning and directing assigned operational and improvement activities, managing a team of supervisors and associates, and driving continuous improvement initiatives. Your leadership will be crucial in maintaining the product quality, developing team members and enhancing business acumen and functional skills within the team.  

How you will make an impact:

• Manage supervisors and oversee the work of the assigned quality assurance team within your function, spanning multiple production lines.
• Conduct comprehensive performance reviews, providing constructive feedback and resolving any performance-related issues to ensure high standards are maintained.
• Collaborate with various cross-functional and cross-site groups to manage the inspection processes of in-process and finished goods, assemblies, and components.
• Ensure proper implementation of inspection procedures and standards to maintain product integrity and compliance.
• Ensure that the product quality status is consistently maintained throughout the production process.
• Provide oversight for the release of products in both intermediate and final states, ensuring they meet all quality standards and specifications.
• Ensure that all positions within the assigned work areas are appropriately staffed.
• Oversee the recruitment, selection, and onboarding processes to build a competent and efficient team.
• Ensure that all staff members are adequately trained to perform their assigned tasks effectively.
• Develop and implement training programs to enhance the skills and knowledge of the team.
• Develop a robust talent development plan that aligns with the functional growth strategies of the department.
• Identify and nurture high-potential employees, providing opportunities for career advancement and professional growth.
• Identify opportunities for process improvements and lead the implementation of strategic initiatives and changes to enhance efficiency, productivity, and quality.
• Utilize data-driven approaches to monitor performance and drive continuous improvement initiatives.
• Be the Key stakeholder providing guidance for inspection related processes in new product transfers from NPD and to other sites. 
• Perform other incidental duties as required to support the overall objectives of the department and organization.

What you’ll need (Required Qualifications):

• Bachelor’s degree with minimum of 8 years in Manufacturing, Quality, and/or Product Development Engineering; or Master’s degree with minimum of 6 years in Manufacturing, Quality, and/or Product Development Engineering
• Current or prior supervisory/people leadership experience
• Experience working within a highly regulated industry

What else we look for (Preferred Qualifications):

• Medical device, pharma, or biotech industry experience preferred
• Project Management & Lean/Six Sigma experience
• Experience with quality inspections and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts and general business operations
• Understanding of the Product lifecycle in medical device, design & development, product commercial scale up & stabilization as well as failure investigations.  
• Regulatory experience in International Standards ISO-13485:2003, ISO 14971:2019 and 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
• Proven track record transforming processes, systems and teams and driving significant change initiatives.
• Knowledge on budgeting, labor forecasting, and strategic planning.
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders to achieve objectives, as well as mediating differences to achieve consensus
• Strong analy