Supplier Quality Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Irvine, CA, 92713

Posted Date : 2 October 2025

Job Type : Other

Category : Industrial Engineering

Occupation : Quality Engineer

Job Details

Job Description:
The Senior Engineer, External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as base business support and nonconformance root cause investigation to maintain and improve customer satisfaction, eliminate errors and improve efficiency. The individual is responsible to build business partnerships with suppliers and internal stakeholders / technical experts (i.e. Procurement, Operations, R&D, Supply Chain, NPI) to eliminate supply chain risks, while implementing continuous and innovative improvements with demonstrated and measurable results.
Responsibilities:

Provide sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues. Includes working with suppliers and internal resources to perform root cause analysis/failure investigations, identifying and approving of supplier corrective actions, and monitoring supplier's implementation / effectiveness. Provides oversight and escalation for product related issues.
Ensure compliant execution of Quality Management Systems including but not limited to EM: selection, change control, qualification, approved supplier list, NC/CAPA, Quality agreements and performance monitoring.
Provide leadership across activities associated with supplier risk identification & management, including planning and execution of supplier risk & control plan assessments and the ownership and creation of Quality Agreements.
Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision.
Adaptable and flexible for other duties that may be assigned as needed.

Requirements:

Senior Supplier Quality Engineer a minimum of four (4) years of relevant work experience.
Hands on production line experience with validations.
NC/CAPA root cause analysis, FMEAs, NPI, Design Control, Supplier Quality, medical device.
Someone already experienced with Pharmaceutical would be preferred for quick onboarding and less learning curve.
Critical thinking skills, excellent written and verbal communication skills with attention to detail.
Demonstrated project leadership experience within regulated quality environment.
The candidate needs to have supervisory skills as he/she will be responsible for meeting the project timelines required for team.
Creation of charts, scheduling etc. using Excel.
Program Management skillset.