Medical Device Quality Engineer I

Job Description

We are seeking a dedicated and detail-oriented Quality Engineer I to join our team. In this role, you will work closely with operations and business functions to ensure the quality performance of products and processes, develop and improve manufacturing processes, and maintain key performance indicators for monitoring process and product quality.

Responsibilities

• Collaborate with operations and business functions to ensure product and process quality performance.
• Work with customers, sales/marketing, field personnel, and cross-functional teams to address quality issues.
• Approve NC/CAPA and build proficiency in problem-solving and root-causing activities.
• Engage in the development and improvement of manufacturing processes for existing products.
• Review change management activities.
• Maintain KPIs for monitoring process and product quality, perform analysis, and interpret trends, taking action as necessary.
• Execute and analyze complaints and product field actions.
• Advocate for Human Factor practices, identifying, reducing, and mitigating human factors.
• Develop an understanding of risk management practices and concepts.
• Optimize inspection methods and sampling.
• Develop proficiency in statistical methods and applications.
• Participate in internal audits and external audit preparation, providing effective narratives and descriptions.
• Assist in the development and review of process and equipment validation/qualification.
• Execute quality activities related to manufacturing transfers to other plants/facilities.
• Initiate, internally contain, and support ship and product holds for potential product escapes.

Essential Skills

• Experience in quality engineering, assurance, and audits.
• Knowledge of supplier, production, and design quality processes.
• Proficiency in ISO standards and familiarity with GDP and GMP.
• Understanding of quality concepts such as risk management, CAPA, audits, and statistics.
• Strong communication, project management, and influencing skills.
• Ability to manage multiple tasks simultaneously and represent the Quality function in project teams.
• Strong interpersonal, written, and oral communication skills.
• Critical thinking and problem-solving skills.
• Strong analytical skills.
• Ability to work independently and as part of cross-functional teams.
• Computer literacy.

Additional Skills & Qualifications

• Previous industry experience desired.
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Understanding of US and International Medical Device Regulations.
• Highly developed problem-solving skills and ability to think outside the box.
• Demonstrated ability to manage and complete projects in a matrix organization.

Work Environment

This position is based onsite in Irvine, CA. The work environment is dynamic and collaborative, offering 2 weeks of PTO and 10 paid holidays. You will have the opportunity to work with cutting-edge technology and be part of a team dedicated to quality and excellence.