Pilot Operations Senior Quality Engineer

Planet Pharma; Irvine (CA); On-site; USD 66,000 - 80,000; Full time

Job summary

Planet Pharma in Irvine, CA is seeking a Pilot Operations Senior Quality Engineer to partner on validation activities for an introducer sheath used in THV devices. This role applies IQ/OQ/PQ knowledge and quality engineering methods to ensure regulatory compliance and reliable device delivery to patients.

Responsibilities include creating validation strategies, reviewing PFMEAs, developing training materials for production, and coordinating technicians.

Qualifications

• Bachelor’s Degree in Engineering or related field with at least 4 years of industry experience required.
• Master’s Degree or PhD preferred depending on level.
• Certifications CQE, Six Sigma or Lean Black Belt preferred.

Responsibilities

• Identify and optimize complex Manufacturing processes using SIX Sigma, LEAN methods for design for manufacturing and continuous process improvement.

Skills

CQE

Six Sigma

Lean Black Belt

Quality Engineering

Documentation

Cross-functional teamwork

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering or related field

Ph.D. in Engineering or related field

Tools

MS Office Suite

Job description

Target PR Range: 48-58/hr DOE

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 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