Quality Engineer

Akkodis is seeking a job Description: Quality Engineer for a contract role in Irvine CA Onsite in United States.

Pay Range: $32/hr -$37/hr ON w2

(The rate may be negotiable based on experience, education, geographic location, and other factors)

job Description: Quality Engineer

Location Irvine CA Onsite

Contract Duration: 12M+(Possible to Extend)

Exp Required : 3-4+ Years

Industry: Medical Devices

Job Summary

We are seeking a Quality Engineer to support our medical device client in Irvine, CA. The ideal candidate will have hands-on experience with CAPA (Corrective and Preventive Action) and NC (Non-Conformance) processes within a regulated medical device environment.

This role will be responsible for supporting quality activities, investigating non-conformances, contributing to CAPA activities, and ensuring compliance with applicable quality systems and regulatory requirements.

Key Responsibilities

• Support the identification, investigation, and resolution of Non-Conformances (NC).
• Participate in CAPA investigations and corrective/preventive action implementation.
• Assist with root cause analysis and development of effective corrective actions.
• Review and analyze quality data to identify trends and recurring issues.
• Support documentation and maintenance of quality records related to CAPA and NC.
• Work cross-functionally with Manufacturing, Engineering, Operations, and other Quality teams to resolve quality issues.
• Ensure quality investigations and documentation are completed accurately and within established timelines.
• Support continuous improvement initiatives related to product and process quality.
• Assist with audits, inspections, and other quality-system activities as required.
• Ensure activities are performed in accordance with applicable medical device quality systems and regulatory requirements.

Required Qualifications

• Bachelor’s degree in Engineering, Quality, Science, or a related technical field.
• Experience working as a Quality Engineer in a medical device or other regulated manufacturing environment.
• Hands-on experience with CAPA processes.
• Hands-on experience with Non-Conformance (NC) investigations and resolution.
• Understanding of root cause analysis and corrective/preventive action methodologies.
• Strong documentation, analytical, and problem-solving skills.
• Ability to work effectively with cross-functional teams.
• Strong communication and organizational skills.
• Ability to work onsite in Irvine, CA.
• Experience with FDA-regulated medical device manufacturing.
• Familiarity with 21 CFR Part 820 / Quality Management Systems.
• Knowledge of ISO 13485.
• Experience with quality tools such as 5 Whys, Fishbone/Ishikawa, Pareto analysis, and risk assessment.
• Experience supporting audits or regulatory inspections.
• Experience with electronic Quality Management Systems (eQMS).

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance