New Product Development QA Manager

The New Product Development QA Manager at SharkNinja is primarily responsible for overseeing the quality management lifecycle of medical aesthetic devices, driving quality planning, conducting risk analysis, and ensuring compliance with regulatory standards such as FDA and ISO 13485. Responsibilities include developing risk management documentation, managing supplier audits, and leading cross-functional quality improvement initiatives.

Candidates for the New Product Development QA Manager position at SharkNinja should possess a minimum of a BS in Mechanical Engineering or a related discipline, and at least 10 years in medical device quality management. Experience in global supplier management and strong knowledge of regulatory requirements, such as ISO 13485 and FDA QSR, are essential.

Success in the New Product Development QA Manager role at SharkNinja requires extensive risk management skills, proficiency with quality tools like FMEA and RCA, and advanced data analytics abilities. The ideal candidate will also have strong communication skills to work effectively with cross-functional teams across global locations.

At SharkNinja, the career path for a New Product Development QA Manager can lead to senior leadership roles within quality management and product development. The company emphasizes personal and professional growth through impactful learning programs, encouraging employees to expand their skills and take on more responsibilities as they demonstrate their capabilities.

Diversity, equity, and inclusion are vital to SharkNinja's success. As a New Product Development QA Manager, you will be supported in bringing your authentic self to work. The company fosters a culture that values unique voices, encouraging collaboration and innovation, making it a welcoming environment for everyone.

Highlight specific methodologies such as DFMEA and PFMEA you've utilized in previous roles. Discuss how you implemented these processes to enhance product quality and mitigate risks, providing examples or results associated with your efforts.

Share your audit methodology, focusing on planning, executing, and reporting findings. Emphasize communication skills and your ability to adapt to different cultural contexts, which are critical when working with suppliers in regions like Southeast Asia.

In your answer, outline the specific problem, the steps you took to diagnose and address it, and the outcomes. Focus on your thought process and collaboration with cross-functional teams to facilitate a resolution.

Discuss your approach to data collection and analysis, the tools you use (like Minitab or JMP), and how you leverage those insights to drive quality improvements or correct any deviations from targets.

Discuss your familiarity with these standards, detailing how you've ensured compliance in your past roles. Provide specific examples of how you've navigated audits or inspections related to these regulations.

Share specific examples of projects where you applied Quality by Design principles, emphasizing how they contributed to proactive risk management and product reliability from the design phase onward.

Illustrate your collaborative approach, providing examples of successful teamwork across departments and how this integration led to improved product quality and successful project outcomes.

Explain your strategy for reviewing and approving engineering change requests, detailing how you assess the impact on quality and compliance, and ensure cross-functional collaboration in the process.

Discuss your project management techniques, including how you evaluate project impact, manage stakeholder expectations, and utilize tools or frameworks to keep projects on track while maintaining quality standards.

Share your passion for quality assurance, emphasizing how it allows you to make a meaningful impact on product safety and effectiveness. Discuss your motivation and excitement for driving innovation and continual improvement.