Quality & Compliance Engineer

US-CA-Rancho Santa Margarita

Overview

Applied Medical, a progressive medical device developer, manufacturer and distributor, invites exceptional individuals to pursue careers in our innovative organization. If you would like to be a part of one of the fastest growing and most innovative companies in the medical device industry, then Applied Medical is the place for you. Applied Medical’s team members enjoy an environment that allows opportunity for growth and choice in individual career paths as team members develop their skills, training and business knowledge. Our common goal of improving healthcare through meeting the needs of clinicians and patients is achieved through the dynamics of our team and its universal dedication to improve patient outcomes.

Position Description

As a Quality and Compliance Engineer, you will be responsible for working within the framework of a product development team to create surgical simulation products and perform the activities listed below. These products are not for clinical use and all the activities listed below will be completed outside of medical regulations.

  • Work closely with Engineering, Clinical Development and Regulatory Affairs to assure appropriate reliability requirements are defined for the specific device application
  • Participate in verification, validation and risk management activities and analysis required to satisfy both regulatory and internal requirements
  • Formalize new testing methodologies and approaches required to complete comprehensive reliability analysis of device designs for simulation devices
  • Work closely with third party test labs and coordinate product compliance and safety testing
  • Coordinate the development and validation of functional test methods and compliance to applicable electrical standards and regulations
  • Establish quality and engineering processes to ensure products are developed and manufactured according to applicable requirements
  • Conduct investigations, root cause analyses and provide corrective and preventive actions based on thorough analyses and reviews
  • Provide effective solutions that will drive continuous and measurable improvements
  • Develop procedures to comply with statutory, regulatory and ISO 9001:2015 requirements
  • Research and determine statutory and regulatory requirements for materials, mechanical products, electro-mechanical products, and software projects
  • Work within a product development team to ensure that the project timelines are met by guiding the Engineering team on regulatory requirements and defining and overseeing certification testing
  • Review product development projects and documentation for completeness and compliance
  • Communicate regulatory requirement activities, voluntary certification activities and certification status/issues to management and cross-functional teams
  • Review and approve label and instruction designs for symbol and text compliance
  • Work closely with global certification bodies to certify and register product
  • Support manufacturing audits from certification bodies

Position Requirements

This position requires the following skills and attributes:

  • BS/BA in Engineering or other related field
  • Experience with ISO 9001
  • 3+ years of experience in regulatory/safety compliance for the consumer electronics or information technology fields
  • Excellent problem-solving skills in areas of product development and engineering compliance
  • Experience with certifying and releasing consumer electronics or information technology devices in the U.S. and EU
  • Experience with RoHS, WEEE, Low Voltage Directive, EMC Testing, and FCC requirements
  • Ability to work in an interdisciplinary team
  • Effective verbal, written and interpersonal communication skills
  • Experience with Microsoft Office Suite and other standard software

Preferred

The following skills and attributes are preferred:

  • 5+ years of experience in regulatory/safety compliance for the consumer electronics or information technology fields
  • Experience with IEC 62366
  • Certified Reliability Engineer or ASQ Certification
  • Experience certifying and releasing consumer electronics in Australia, Korea, Mexico, and Japan
  • Experience with product safety and risk analysis methods
  • Hands-on ability to perform safety testing
  • Experience in product design
  • Experience writing procedures within a Quality Management System based on regulatory requirements
  • Experience with Microsoft Project and other project management tools

Benefits

Applied Medical offers an excellent and competitive compensation and benefits package including medical and dental coverage, flexible benefits account, 401(k), and generous holiday and vacation accrual schedules. 

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