Engineer, Quality

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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!