Engineer, Quality
Experis • Temecula, California, US
11 hours ago
Salary
$35.00 hourly
Job type
- Contractor
Job description
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!