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Quality Assurance Inspector

2 months ago

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

Applied Medical is a pioneering medical device organization known for its innovative approach and rapid growth trajectory. With over 35 years of experience in developing and manufacturing cutting-edge surgical technologies, we have established a solid reputation for excellence in the healthcare sector. Our unique operational model, coupled with our commitment to delivering superior quality products, allows our team members to make significant contributions beyond typical roles.

Position Overview

We are in search of a meticulous and dedicated Quality Assurance Inspector to become a vital part of our team at Applied Medical. In this role, you will be instrumental in ensuring that our medical devices adhere to regulatory standards and quality benchmarks. Your responsibilities will include inspecting, testing, and documenting various phases of the manufacturing process to ensure product integrity and compliance.

Key Responsibilities:

  • Inspection and Testing: Perform First Article and Final inspections utilizing a range of measuring instruments and equipment, including pin gauges, calipers, micrometers, rulers, optical comparators, and Keyence systems.
  • Quality Assurance: Familiarize yourself with and adhere to Applied Medical's Quality Systems (QS), safety protocols, and company policies.
  • Documentation: Assess Medical History Record (MHR) operations for precision, traceability, and adherence to good documentation practices (GDP). Utilize Enterprise Resource Planning (ERP) software to record inspection outcomes, receiving, quarantine, Technically Complete (TECO), material release, and scrap management.
  • Training and Compliance: Stay informed about industry standards, regulations, and best practices related to quality control and assurance. Provide training and support to production personnel on quality expectations and inspection methodologies.
  • Team Collaboration: Work collaboratively with cross-functional teams, including production, engineering, and regulatory affairs, to address quality-related challenges and implement corrective measures.
Performance Objectives:

Within your first 30 days:
  • Complete training on company policies, procedures, and quality control protocols.
  • Become acquainted with the production environment and key stakeholders.
  • Conduct initial inspections of medical devices under supervision.
  • Begin documenting inspection results and maintaining precise records.
  • Identify immediate areas for enhancement in quality control processes and propose solutions.
Within 60 days:
  • Carry out independent inspections with minimal oversight.
  • Exhibit proficiency in executing tests and measurements according to established protocols.
  • Consistently document inspection results accurately and efficiently.
  • Identify and report recurring quality issues, collaborating with the team to implement corrective actions.
Within 90 days to 1 year:
  • Act as a resource for fellow team members on quality control procedures and best practices.
  • Proactively seek opportunities to optimize quality control processes and enhance efficiency.
  • Successfully complete any additional training or certifications pertinent to the role.
  • Contribute to the development and execution of new quality initiatives or process improvements.
  • Maintain a high standard of quality and compliance in all aspects of work, contributing to the overall success of the organization.
Position Requirements:
  • High school diploma or equivalent.
  • Ability to work independently and collaboratively within a team.
  • Strong analytical skills with a meticulous and detail-oriented approach.
  • Proactive attitude, demonstrating assertiveness and the ability to seek clarification through thoughtful inquiries.
  • Effective oral and written communication skills, with proficiency in English.
  • Friendly demeanor, positive attitude, and a customer service-oriented mindset.
  • Willingness to learn how to operate various measuring tools and equipment.
  • Ability to work independently and efficiently in a fast-paced environment that challenges mental acuity.
  • Excellent time management and organizational skills.
Preferred Qualifications:
  • At least two years of relevant experience.
  • Experience with optical comparators and Nikon vision systems.
  • Familiarity with the SAP system.
  • Basic understanding of inspecting raw materials, components, and sub-assemblies.
If you are passionate about making a meaningful impact, driving innovation, and contributing to a dynamic team, we invite you to explore this opportunity at Applied Medical. Our unique operational model empowers our team members to have a substantial impact, unlike conventional roles.

Benefits:
  • Competitive compensation range.
  • 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.