Job Title: Quality Engineer II

Job Description

As a Quality Engineer II, you will play a crucial role in ensuring the quality performance of products and processes. You will collaborate with operations, business functions, and cross-functional teams to address top quality issues and improve manufacturing processes. Your expertise will contribute to product and process excellence, and you will engage with customers, sales, marketing, and field personnel to uphold high quality standards.

Responsibilities

• Work closely with operations and business functions to ensure quality performance of products and processes.
• Collaborate with customers, sales, marketing, field personnel, and cross-functional teams to address quality issues.
• Approve non-conformance reports and corrective and preventive actions (NC/CAPA).
• Engage in the development and improvement of manufacturing processes for existing products.
• Review change management activities.
• Maintain key performance indicators (KPIs) for monitoring process and product quality, perform analysis, interpret trends, and take necessary actions.
• Execute and analyze complaints and product field actions.
• Advocate for Human Factor practices, identifying, reducing, and mitigating Human Factor issues.
• Develop understanding of risk management practices and concepts.
• Optimize inspection methods and sampling processes.
• Develop proficiency in statistical methods and applications.
• Engage in internal audits and participate in external audit preparations.
• Assist in the development and review of process and equipment validation and qualification.
• Participate in manufacturing transfers to other plants or facilities and execute quality activities.
• Initiate, internally contain, and support ship and product holds for potential product escapes.

Essential Skills

• Proficiency in quality engineering, quality assurance, supplier quality, production quality, and design quality.
• Experience in quality audits and familiarity with ISO standards.
• Knowledge 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 with project teams.
• Strong interpersonal, written, and oral communication skills.
• Strong problem-solving and analytical skills.
• Ability to work independently and as part of cross-functional teams.
• Computer literacy.

Additional Skills & Qualifications

• Previous industry experience is desired.
• Experience interacting with regulatory agencies such as FDA, MoH, TUV is desired.
• Understanding of US and International Medical Device Regulations.
• Familiarity with ISO, GDP, and GMP is desired.
• Demonstrated ability to manage and complete projects in a matrix organization.
• Ability to think critically and "outside the box".

Work Environment

This position is based onsite in Irvine, CA. The work environment is dynamic, offering opportunities to engage with various teams and participate in both internal and external quality audits.