Quality Engineer I - Exempt

We are seeking a dedicated and detail-oriented Quality Engineer to join our team in Santa Ana, CA. This role offers the opportunity to work in a dynamic environment, focusing on ensuring the highest quality standards for Class III medical devices. If you are looking to start or advance your career in quality engineering, this position offers a great opportunity to grow and develop your skills.
Primary Responsibilities

• Lead complaint investigations and conduct periodic trending of complaint data to evaluate negative trends and assess risks to released products.
• Collaborate with cross-functional teams including customer quality experience management, clinical affairs, medical safety, R&D engineering, and manufacturing to perform thorough complaint investigations.
• Prepare appropriate responses to regulatory queries for product registrations and other submissions by working with the regulatory affairs team.
• Partner with the design assurance team on risk analysis of new products by reviewing files such as product hazard analysis, DFMECA, post-market surveillance plans, and risk management reports.
• Own and maintain the periodic safety update report (PSUR) by collaborating with several cross-functional teams for applicable devices.
• Develop solutions to unique issues with a wide range of difficulty, improving existing processes and systems.
• Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis, and review for the success of the business.

Additional Responsibilities

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Technical Specialist Career Stream
This role is an entry-level individual contributor position with responsibilities in advancing existing technology or introducing new technology and therapies. You will formulate, deliver, and/or manage projects assigned and work with other stakeholders to achieve desired results. The majority of your time will be spent delivering R&D, systems, or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
Key Qualifications

• B.S. degree required.
• 0-2 years of experience required.
• Ability to work under pressure and manage stress, achieving weekly goals in terms of closing all assigned complaints each week.
• Attention to detail and the ability to avoid repeating errors on routine tasks.

If you are passionate about quality engineering and eager to contribute to meaningful projects, we encourage you to apply for this exciting opportunity in Santa Ana, CA.