Quality Assurance Specialist

4 days ago


Rancho Santa Margarita, California, United States Applied Medical Full time
Job Summary

We are seeking a detail-oriented and analytical Quality Assurance Specialist to join our team at Applied Medical. As a Quality Assurance Specialist, you will play a crucial role in ensuring that our medical devices meet regulatory requirements and quality standards.

Key Responsibilities:
  • Inspection and Testing: Conduct incoming material inspections using a variety of measuring tools and equipment, such as pin gauges, calipers, micrometers, rulers, optical comparators, and/or Keyence.
  • Quality Assurance: Understand and comply with Applied Medical's Quality Systems (QS), safety rules, and company policies.
  • Documentation: Review receiving inspection paperwork and use the Enterprise Resource Planning (ERP) system software to document inspection results, receiving, quarantine, and release of material and scrap.
  • Training and Compliance: Stay updated on industry standards, regulations, and best practices related to quality control and quality assurance. Provide training and guidance to production staff on quality requirements and inspection techniques.
  • Team Collaboration: Collaborate effectively with cross-functional teams, including production, engineering, and regulatory affairs, to resolve quality-related issues and implement corrective actions.
Performance Objectives:
  • Within your first 30 days:
    • Complete training on company policies, procedures, and quality control processes.
    • Gain familiarity with the production environment and key stakeholders.
    • Perform receiving inspections of raw materials under supervision.
    • Begin documenting inspection results and maintaining accurate records.
    • Identify any immediate areas for improvement in quality control processes and suggest solutions.
  • Within 60 days:
    • Conduct independent inspections with minimal supervision.
    • Demonstrate proficiency in performing tests and measurements according to established protocols.
    • Consistently document inspection results accurately and efficiently.
    • Identify and report any recurring quality issues and collaborate with the team to implement corrective actions.
  • Within 90 days to 1 year:
    • Serve as a resource for other team members on quality control procedures and best practices.
    • Proactively identify opportunities to streamline quality control processes and improve efficiency.
    • Successfully complete any additional training or certifications relevant to the role.
    • Contribute to the development and implementation of new quality initiatives or process improvements.
    • Maintain a high level of quality and compliance in all aspects of work, contributing to the overall success of the company.
    Position Requirements:
    • Education: High school diploma or equivalent.
    • Skills: Demonstrate proficiency in both independent work and collaborative teamwork. Exhibit strong analytical skills with a meticulous and detail-oriented approach. Display assertiveness and a proactive attitude, unafraid to seek clarification through thoughtful questions.
    • Communication: Possess effective oral and written communication and presentation skills, with proficiency in English.
    • Attitude: Showcase a friendly demeanor, positive attitude, and a customer service-oriented mindset.
    • Technical Skills: Learn how to use a variety of measuring tools and equipment.
    • Work Environment: Work independently and effectively in a fast-paced work environment that challenges mental aptitude.
    • Time Management: Possess excellent time management and organizational skills.
    • Certification: Forklift certification or willingness to become certified.
    Preferred Qualifications:
    • Experience: Minimum two years of related experience.
    • Technical Skills: Experience utilizing optical comparator and Nikon vision system.
    • Software Skills: Experience with the SAP system.
    • Knowledge: Entry-level understanding of inspecting raw materials, components, and sub-assembly.


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