Principal Quality Engineer

MiniMed•Northridge, CA

5d•$109,000 - $185,000•Onsite

About The Position

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world. About the Role Are you a seasoned quality engineering professional with a passion for precision, compliance, and making a meaningful impact? We are looking for an experienced Quality Engineer to join our on-site manufacturing team at MiniMed, a leader in innovative diabetes management solutions. In this critical role, you will serve as a cornerstone of our day-to-day manufacturing quality operations ensuring our products meet the highest standards of accuracy, reliability, and regulatory compliance. You will play an integral part in the launch of next-generation medical device products, leading test method validations, driving risk mitigation strategies, and collaborating with cross-functional teams to bring life-changing technology to patients who depend on it. This is an opportunity to directly influence product integrity and patient outcomes in a fast-paced, highly regulated medical device environment. If you are a detail-oriented, proactive, and collaborative quality professional who thrives on solving complex challenges and delivering results, this role is for you. Ready to make an impact? Apply now and join our team!

Requirements

Bachelor’s degree with 7+ years’ relevant experience, or Advanced degree with 5+ years of experience.

Nice To Haves

Proficiency in statistical analysis tools such as Minitab or equivalent, with hands-on experience applying statistical process control (SPC), Design of Experiments (DOE), and data-driven problem-solving methodologies to drive quality improvements in a high-volume manufacturing setting.
Proven experience in Corrective and Preventive Action (CAPA) ownership, including the ability to lead end-to-end CAPA investigations, perform thorough root cause analyses using methodologies such as 8D, Fishbone, and 5-Why, and drive timely, sustainable corrective actions to closure in compliance with regulatory requirements.

Responsibilities

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Leads quality engineering activities in support of new product introduction (NPI), including design transfer, process validation, and launch readiness assessments, to ensure a smooth transition from development to full-scale manufacturing in compliance with regulatory and quality requirements.
Proactively identifies, evaluates, and mitigates quality risks across the manufacturing process utilizing risk management tools such as FMEA, Control Plans, and ISO 14971 frameworks to prevent quality escapes and minimize impact to production schedules and customer deliverables.
Develops, executes, and maintains test method validations (TMV) including method development, qualification, and revalidation activities to ensure measurement systems are accurate, reliable, and compliant with applicable regulatory standards and internal quality requirements.