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Quality Assurance Specialist in Aliso Viejo, CA at Nelson

Date Posted: 4/30/2018

Job Snapshot

Job Description

Job Number: 2119199

Job Title: Quality Assurance Specialist

1. Maintain Quality System records.

2. Perform clerical functions associated with the companies Quality System.

3. Interact with individuals within compnay to provide needed Quality System documentation such as verification/validation protocols and reports.

4. Perform receiving inspection activities including verification of device history records and appropriate certifications.

5. Check daily shipments for compliance to sales order and verification of lot numbers.

6. Assist with documentation control processing, routing, and control.

7. Track equipment calibration and assist with processing.

8. Evaluate, document and control nonconformance product as required.

9. Work with Quality Manager to coordinate internal corrective action activities and complete follow-up evaluations to determine completion and effectiveness of corrective actions.

10. Work with Quality Manager to coordinate supplier corrective action activities for supplier quality issues.

11. Track customer complaints and assist with investigation and analysis.

3-5 Years experience in medical/pharmaceutical manufacturing/quality department

Must demonstrate knowledge of FDA Quality System Regulation (CFR 21 Part 820), ISO 13485:2012, Medical Device Directive and best industry practice for medical device compliance.

Ability to read and understand technical drawings.

Strong knowledge and previous application of Excel, Word. Knowledge of FileMaker Pro, Crystal Reports and Great Plains is a plus.

Excellent organizational skills, strong statistical skills, independent thinking, and a high level of initiative are a must

Possible temp to hire opportunity

About Nelson:

For more than 45 years, we've been passionate about helping people find jobs they love - rewarding jobs that further career goals. At Nelson, we partner with companies that have outstanding reputations. Working with innovative startups to Fortune 500 companies, our skilled recruiters have access to opportunities beyond what you can find on your own.

With Nelson, you'll get the most out of your career. Together, we'll set career goals and find you a position where your skills shine. Whether you are looking for a position in: accounting & finance, administration, computer gaming, digital media, engineering, human resources, legal, light industrial, manufacturing, or technology, Nelson helps place people in full-time, temporary, temp-to-hire, project, and contract positions. For a full listing of jobs, go to: and click "Find Work."