Sr Quality Engineer (Automated Equipment)

We are seeking a Senior Quality Engineer to work on a team at our client site in Irvine, CA. The W2 hourly rate range is $55.00 to $59.16 per hour. The role is with

Roth Staffing (Ultimate Staffing and Ledgent Tech are divisions of Roth Staffing. No 3rd party candidates can be considered for this role.

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

• This is a decided project - Program that needs to get to PQs
• Analyzing equipment and protocols
• Read protocols
• IQs, OQs, PQs - really understanding the product and the equipment
• Technicians will execute the protocols, so this role will need to be able to guide the technicians.
• Quality engineering - process validation
• Open to manufacturing engineers that have quality experience
• Sr Engineering role - so needs at least 4+ years of exp
• Top Skills
• Technical aptitude - new equipment so she wants them to challenge what's written
• Attention to detail
• Collaboration - not everything will go to plan, needs to be able to escalate timely and mitigation impacts
• Minitab - for data analysis. Reviewing reports and reading the data
• Open to other industries as long as they have experience with automated equipment
• 100% onsite - open to reviewing non local candidates if they can relocate to Irvine on their own in a timely manner

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 Edwards' 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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.