Quality Management Representative / Lead Auditor

Phononic’s unrivaled approach to solid state cooling is breaking the boundaries of semiconductor innovation to deliver unprecedented performance and sustainability across the globe. From disrupting refrigeration and freezing, to cooling pinhead-sized fiber optics components, Phononic’s technology takes infinite forms to unseat the wasteful and unreliable cooling solutions of the past, which depend on bulky compressors, noisy fans and noxious gases simply not suited for the modern world. Phononic is transforming the way life-saving drugs and vaccines are protected, data is transmitted and food and beverages are sold, stored and transported. The company has been named to the 2016 and 2017 CNBC Disruptor 50 lists, received the US EPA’s 2017 Emerging Tech Award, R&D 100 Award and more. For more information visit www.phononic.com.

SUMMARY OF ROLE

Phononic is looking for an experienced Quality Professional to manage implementation and sustaining of our ISO systems. This individual must have experience with successfully implementing ISO systems within a small company with aggressive growth. This individual will lead and manage the Internal Audit team, Document Control systems, as well as supporting the company CAPA systems. This strong leader will play a key role in ensuring compliance with FDA requirements and ISO standards thru continuous monitoring of the supplier processes.

ESSENTIAL FUNCTIONS

  • Lead transitions to ISO14001 and ISO13485 QMS
  • Continued monitoring and auditing of current ISO9001 QMS
  • Lead and train Internal Audit team
  • Drive continuous improvement of our ISO QM systems thru CAPA generated from Internal Audits
  • Consolidate Phononic Document Control systems to a single system that is utilized by all functional groups, including facilitating implementation and training to all involved persons
  • Develop and execute audit plans at CM location for all relevant agency compliance (FDA, ISO, IPC, etc). Drive supplier actions to correct audit nonconformance and ensure compliance to Suppliers’ Quality System.
  • Provide oral/written presentations in order to report status of quality issues and CM trends.

MINIMUM REQUIREMENTS

Bachelor’s degree and at least 3 years of hands on experience with ISO system management experience within a manufacturing or engineering environment, or equivalent combination of education and experience. Experience in the manufacturing of OEM electro-mechanical consumer products preferred.

Proven experience in implementing an ISO system in an environment with little or no ISO experience. Experience in successfully closing Internal Auditing CAR to prevent similar occurrences in the future. Proven track record of being able to work independently at identifying and fixing problems. Experience in ISO9001 and ISO14001 is required. Experience in FDA and IPC compliance preferred. Quality Systems Auditor certification preferred

  • Excellent interpersonal skills, proven organizational skills; ability to multi-task and work on several assignments concurrently; detail oriented.
  • May be required to travel domestic and international as needed.Email resume in position inquiries to david.gaussiran@phononic.com.

Phononic is proud to be an equal opportunity employer