Senior Quality Engineer

TalentBurst•Irvine, CA

1d•Onsite

About The Position

This Pilot Operations Senior Quality Engineer role partners on the validation activities for an introducer sheath for the Transcatheter Heart Valve (THV) Business Unit. 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 the client’s systems/procedures to deliver much needed devices to patients.

Requirements

Bachelor's Degree in Engineering or related field, 4 years of related industry experience required
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 to plant sites
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 the environment and prevention of pollution under their span of influence/control

Nice To Haves

Master's Degree or equivalent in Engineering or related field, 3 years of related industry experience preferred
Ph.D. or equivalent in Engineering or related field, 0 years of related industry experience preferred
Certifications CQE (Certified Quality Engineer), Six Sigma or Lean Black Belt preferred
Previous experience working with lab/industrial equipment preferred

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; train technicians and provide feedback; and may coordinate technician work.
Other incidental duties assigned by Leadership