Quality Process Engineer 1

Sanders Industries HoldingsSan Clemente, CA

About The Position

IRP Medical is seeking a Quality Process Engineer 1 who will support various aspects of IRP Medical’s Quality Management System, ensuring world-class systems and performance through a continual focus on process improvement, supplier development, and customer interaction. Support a culture of Continuous Improvement and positive Customer Experiences. IRP Medical is a trusted leader in engineered elastomer solutions serving Medical Device, and aerospace markets. Our team designs and manufactures precision-molded seals, gaskets, and custom rubber components that perform in the most demanding environments. We take pride in craftsmanship, collaboration, and a culture built on innovation and reliability.

Requirements

  • Bachelor’s Degree required, Engineering discipline preferred
  • 1+ years working in the Medical Device and aerospace industry
  • Ability to manage priorities and meet deadlines in a fast-paced environment
  • Working knowledge of ISO-13485 and ISO-9001 Quality Management System processes.
  • General knowledge of Medical Device requirements
  • Working understanding of partnering with manufacturing via applying Engineering and Quality understanding to improve quality, reduce cost, improve lead time, and drive efficiencies
  • Basic experience with root cause analysis and corrective action
  • Capable of reviewing and interpreting drawings, contracts / POs, and applicable processing standards
  • Basic understanding in the use of digital/analog measuring instruments, e.g., micrometers, calipers, linear and dial gauges, height gauges, and a visual comparator
  • Proficiency with MS Office applications: Word, Excel, PowerPoint, and Outlook

Responsibilities

  • Quality Process Engineering responsibility for composites and polymers processes
  • Quality Champion and change agent for assigned areas of responsibility
  • Implement and maintain the Cost of Quality system
  • Work closely with Engineering and Operations to ensure that designs can be manufactured with repeatable Quality
  • Support Quality and Production initiatives and develop and facilitate improvement teams
  • Provide Quality function support by working closely with Sales, Engineering, and Operations to manage customer relations, expectations, needs, and satisfaction
  • Independently drive and direct actions with departmental groups to maintain MRB and RMA issues
  • Support key Quality performance metrics: DPPM, OTD, Cost of Quality, Customer Scorecards, , and Supplier Performance
  • Formulate and maintain quality assurance/control objectives complementary to organization policies and goals.
  • Create and implement inspection criteria and procedures.
  • All other duties and tasks as required.

Benefits

  • medical
  • dental
  • vision
  • short and long-term disability coverage
  • accident insurance
  • critical illness insurance
  • basic and supplemental life insurance
  • employee assistance plan
  • retirement savings and matching
  • other developmental opportunities
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