Sr Quality Engineer

Ledgent Technology; Irvine (CA); On-site; USD 76,000 - 81,000; Full time

Job summary

Ledgent Technology in Irvine, CA seeks a Pilot Operations Senior Quality Engineer to lead validation activities for introducer sheath devices for THV. The role focuses on applying IQ/OQ/PQ and standard QA methods to ensure regulatory compliance and patient safety.

The candidate will review validations, assist in strategy development, and maintain risk management and training materials for production teams, with a strong emphasis on leadership and cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering or related field required.
• Master's degree or Ph.D. in Engineering or related field preferred.
• CQE (Certified Quality Engineer), Six Sigma or Lean Black Belt certifications preferred.
• Proven MS Office proficiency and documentation skills required.

Responsibilities

• Identify and optimize complex manufacturing processes using Six Sigma, Lean, and related methods.
• Review and approve equipment validations and asset management actions.
• Develop validation strategies and review PVP/MVP scopes.
• Ensure validation scope aligns with use, risk, and regulatory requirements.
• Review PFMEAs and process risk assessments to verify CPPs and CQAs addressed.
• Coordinate prerequisite activities (equipment qualification, software validation, etc.).
• Develop training and documentation for production to transfer knowledge.
• Lead and coordinate technicians, assign tasks, and provide feedback.

Skills

Six Sigma

Lean

Leadership

Problem solving

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Ph.D. in Engineering

Tools

MS Office Suite

Job description

Sr Quality Engineer (JN -092026-431960) Irvine, California

Salary: USD55 - USD59 per hour

Pay: $55.00 - $59.00 per hour

Job Summary

This Pilot Operations Senior Quality Engineer role partners on the validation activities for an introducer sheath for the Transcatheter Heart Valve (THV) Business Unit.

Job Description

• Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. In this role, you will apply your IQ/OQ/PQ knowledge as well as quality engineering principles and methods to ensure compliance with regulatory requirements and company systems/procedures to deliver much needed devices to patients.

Key Responsibilities:

• Identify and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement.
• Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Review and approve equipment validations and asset management actions.
• Participate in validation strategy development and review the PVP/MVP.
• Ensure validation scope aligns with intended use, risk assessment, and regulatory requirements.
• Review PFMEAs and process risk assessments to verify critical process parameters (CPPs) and critical quality attributes are adequately addressed.
• Confirm prerequisite activities are complete (equipment qualification, TMV, software validation, fixture qualification, drawing release status, etc.).
• Verify statistical rationale, sampling plans, and acceptance criteria are appropriate.
• Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership

Education and Experience:

• Bachelor's Degree in Engineering or related field, 4 years experience related industry experience Required or
• Master's Degree or equivalent in Engineering or related field, 3 years experience related industry experience Preferred or
• Ph.D. or equivalent in Engineering or related field, 0 years experience related industry experience Preferred

Additional Skills:

• Certifications CQE (Certified Quality Engineer), Six Sigma or Lean Blackbelt preferred
• Proven expertise in usage of MS Office Suite
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques will be required for work related plant sites
• Previous experience working with lab/industrial equipment preferred
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control