Engineer, Quality

Experis-US; Temecula (CA); In loco; USD 48.000 - 54.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending Array

Supplemental Life Insurance

Short Term Disability Insurance

Long Term Disability Insurance

Business Travel Insurance

Weekly Pay

401(k) Plus Match

Descrizione del lavoro

Experis Technology Group is seeking a Quality Engineer for 100% onsite work in Temecula, CA. The role focuses on medical device QA activities aligned with FDA QSR and ISO 13485 standards.

Responsibilities include developing inspection processes, supporting product quality throughout production, managing sterilization validations, and leading MRB and complaint investigations. Competitive W2 pay is offered.

Competenze

• Experience in medical device quality systems (FDA QSR)
• Ability to develop and maintain incoming inspection processes
• Strong capability to lead corrective actions and quality improvements
• Experience with supplier interfaces and MRB activities

Mansioni

• Initiate and support QA activities per FDA QSR/ISO 13485.
• Develop incoming inspection processes and related documentation.
• Provide in‑process QA support including inspection and document reviews.
• Manage sterilization process validations and sterile loads.
• Track nonconforming material and lead MRB efforts.
• Lead complaint investigations and failure analyses for returned products.

Conoscenze

Quality assurance

FDA QSR

ISO 13485

Medical devices

Descrizione del lavoro

Job Title: Quality Engineer

Location: Temecula, CA - 100% Onsite

Pay Range: $35/hr to $39/hr on W2

What's the Job?

Initiate and support medical device quality assurance activities in accordance with FDA Quality System Regulation, ISO 13485, and other international standards. Develop incoming inspection processes and document incoming inspection activities to ensure materials and components meet requirements. Provide in-process QA support, including inspection and document review, to help maintain product quality throughout production. Complete final acceptance activities and manage the sterilization process, including validations and product sterile loads. Track nonconforming material, lead Material Review Board (MRB) efforts, and take the lead on complaint investigations and failure analysis for returned product.

What's Needed?

Experience supporting quality systems for medical devices, with working knowledge of FDA Quality System Regulation and ISO 13485 expectations. Ability to develop and maintain inspection processes, including documentation of incoming inspection activities and quality records. Competence in managing corrective action and quality improvement activities, including quality system follow-through. Strong capability to interface with suppliers, contractors, and consultants, taking a lead QA role for components, subassemblies, and contract processing. Experience supporting internal quality system auditing and establishing, monitoring, and evaluating quality system metrics.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay