QA Associate

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As a Quality Assurance Associate, you will play a crucial role in ensuring the highest standards of quality for our 3D‑printed products and services. Your focus will be on supporting and organizing critical Master Batch Records (MBRs) and Certificates of Conformance while supporting quality control activities such as data entries (ERP System), lean manufacturing/scheduling, record archiving, documenting training records, and supporting change controls.

• Company Culture and Mission:
  • Consistently apply core values (Integrity, Impact, Dedication) to your decision‑making process and interactions with others.
  • Uphold and contribute to the company’s quality policy commitment.
• Master Batch Records:
  • Prepare master batch record job folders for new production builds.
  • Support and organize records and data entries to allow for approvals in a timely manner with an accurate compilation of product Master Batch Records, which include Certificates of Conformance.
  • Assist in verifying manufacturing scheduling to ensure that all quality activities are occurring at or ahead of schedule.
  • Using Microsoft Word, Excel, and JobBoss2 document and record data entries in cooperation with handwritten records.
  • Review executed records for compliance, ensuring completeness of all necessary testing and documents across various processes as needed.
• Quality Control Records:
  • Archive, physically retain, print and electronically manage records with scanning, filing, and sorting per quality standards.
  • Ensure product processes adhere to established quality standards and guidelines.
  • Support data collection and monitor data throughout the production process where needed.
• Defect Detection/Nonconformances:
  • Collaborate and support the identification and documentation of defects, nonconformance, or deviations from quality standards.
  • Work closely with quality leadership and production teams to address and resolve quality issues promptly.
  • Support corrective actions to prevent the recurrence of defects as needed.
• Training and
  
  Education:
  • Stay updated on industry trends, quality standards, and regulations as needed.
  • Support the maintenance of training records and training matrices.
• Shipping Receiving:
  • Assist with front‑office incoming receiving and outgoing shipments for both products and supplies.
  • Assist in developing and performing quality checks and documentation for incoming materials.
• Communication:
  • Effectively communicate quality‑related information to supervisors, colleagues, and other relevant stakeholders.
• Compliance:
  • Comply with ISO 13485 Quality Management System, FDA 21 CFR Part 820 Quality System Requirements (QSR), and medical device industry requirements.
  • Assist in the implementation of the quantity management system.
• Other work‑related tasks as assigned.

• Understanding of quality control principles and inspection techniques.
• Strong understanding of GMPs and GDP for production and generation of batch records.
• Basic familiarity with mechanical testing and materials characterization.
• Excellent organizational skills.
• Basic ability to read and interpret engineering drawings and specifications.
• Problem‑solving and troubleshooting skills.
• Organizational and time‑management skills.
• Very strong attention to detail.
• Strong commitment to safety and quality assurance.
• Effective communication and interpersonal skills to work with cross‑functional teams.

• Associate degree in a related field and/or 18 months–4 years’ experience preferred.
• Experience in quality control in the medical device industry, aerospace, or automotive industry preferred.
• Experience with mechanical testing and materials characterization preferred.

This is a Contract to Hire position based out of Carlsbad, CA.

The pay range for this position is $25.00 – $30.00 /hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits…