Quality Inspector

2 months ago

Rancho Santa Margarita, United States Applied Medical Full time

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

We are seeking a diligent and detail-oriented Quality Inspector to join our team at Applied Medical. As a Quality Inspector you will play a crucial role in ensuring that our medical devices meet regulatory requirements and quality standards. This position involves inspecting, testing, and documenting various stages of the manufacturing process to guarantee product integrity and compliance.

Key Responsibilities:

  • Inspection and Testing: Conduct First Article and Final inspections using use a variety of measuring tools and equipment such as pin gauges, caliper, micrometer, ruler, optical comparator, and Keyence.
  • Quality Assurance: Understand and comply with Applied Medical's Quality Systems (QS), safety rules, and company policies.
  • Documentation: Review Medical History Record (MHR) operations for accuracy, traceability, and good documentation practices (GDP). Use the Enterprise Resource Planning (ERP) system software to document inspection results, receiving, quarantine, Technically Complete (TECO), 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 initial inspections of medical devices 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
  • High school diploma or equivalent
  • 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.
  • Possess effective oral and written communication and presentation skills, with proficiency in English.
  • Showcase a friendly demeanor, positive attitude, and a customer service-oriented mindset.
  • Learn how to use a variety of measuring tools and equipment.
  • Work independently and effectively in a fast-paced work environment that challenges mental aptitude.
  • Excellent time management and organizational skills
Preferred
  • At least two years' related experience.
  • Experience utilizing optical comparator and Nikon vision system.
  • Experience with the SAP system.
  • Entry-level understanding of inspecting raw materials, components, and sub-assembly.
If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles.

Benefits
  • Competitive compensation range: $18 - 21 / hour (California).
  • Comprehensive benefits package.
  • Training and mentorship opportunities.
  • On-campus wellness activities.
  • Education reimbursement program.
  • 401(k) program with discretionary employer match.
  • Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

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