Principal Quality Mfg Engineer, Selution

$93,816 - $160,000/Yr

Cordis - Irvine, CA

Full-time - Senior

Irvine, CA

Miscellaneous Manufacturing

About the position

The Principal Manufacturing Quality Engineer will serve as the quality representative within the operations team at Cordis, focusing on ensuring that medical devices meet the highest quality standards throughout the manufacturing process. This role involves overseeing quality programs, guiding the operations team through production scale-up, and ensuring compliance with regulations and customer requirements. The engineer will collaborate with cross-functional teams to drive process improvements and foster a culture of quality excellence, ultimately supporting the organization in bringing new therapies to market.

Responsibilities

• Operations lead which includes manufacturing oversight and manufacturing dependent upstream and downstream processes.
• Manufacturing primary point of contact for the engineering team supporting direct manufacturing.
• Quality Control oversight: Supporting the engineers to monitor and implement quality control measures at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements.
• Process Improvement: Lead the engineers through continuously identifying and implementing process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency.
• Risk Assessment: Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
• Regulatory Compliance: Stay up-to-date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.
• MDR: Primary point of contact for the quality operations team for MDR, with potential for this position to assume the quality program manager on MDR.
• Supplier Collaboration: Work closely with supplier engineering group to assess and improve the quality of incoming components and materials, fostering strong supplier relationships.
• Root Cause Analysis: Lead the team through investigation and resolution of quality issues by performing root cause analysis and implementing corrective and preventive actions.
• Documentation: Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP).
• Training: Provide training to manufacturing personnel on quality-related procedures, standards, and best practices.
• Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality.
• Product Testing: Oversee and coordinate product testing, validation, and verification processes to ensure products meet required specifications.
• Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization.
• Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• At least 8 years in medical device production development.
• Previous experience with product lifecycle (post market) commercial support.
• Previous experience leading programs supporting business and regulatory strategy.
• Previous experience working in a clean room environment (preferred).
• Strong engineering and quality background.
• Proven track record in global regulatory body interactions.
• Strong communication skills.
• Global, International Orientation.
• Ability to make independent decisions.
• Fluent in English.

Benefits

• Competitive salary based on experience and qualifications.
• Opportunities for professional growth and development.
• Inclusive work environment that values diversity.