ATL Technology
  • 14-Jun-2019 to 13-Aug-2019 (MST)
  • Quality
  • Springville, UT, USA
  • TBD
  • Salary
  • Full Time

Medical/Dental/Vision/Life/AD&D/STD/LTD - 401K - PTO and small on site gym.

Quality Engineer Needed! One with a great aptitude for learning, being solution driven, and able to focus on both internal and external customer requirements. Our ideal candidate would have a quality improvement mindset with that ability to work in a team environment as well as on their own. 

Essential Duties and Responsibilities:

  • Participate as a member of cross functional teams to address advanced quality planning activities in Medical Device Contract Manufacturing environment including Risk Management, ORT, pFMEA, Supplier Selection and Qualification, Inspection Plans, and Control Plans supporting new product launches
  • Participate as a member on business teams to address Corrective and Preventive Corrective Actions using brainstorming, 5-Why, Cause & Effect and other proven problem solving techniques to deliver problem solving methods to the factory products and processes
  • Assure consistency of the Product Inspection methods and criteria across the enterprise leveraging statistical techniques and Measurement Systems
  • Review site CAPA process including formal, effective and detailed reviews to assure the business makes progress in problem solving with verification of corrections and tracking of results.
  • Participate as a member in the NCMR & MRB process to assure the segregation of suspect materials and the timely assignment of corrective actions and tracking of results.
  • Participate as a member of cross functional engineering teams to apply Process Validation methods based upon Risk Management processes in a Contract Manufacturing environment
  • Deliver Customer confidence thru well performing systems with objective evidence of records and Customer Satisfaction thru product and service results,
  • Participates as a member on Quality team to improve the site Quality Management Systems (QMS) demonstrating compliance to ISO standards and FDA regulations (cGMP) for a full-service site including interfacing with procurement & engineering activities.
  • Other duties and responsibilities as assigned.

Other Knowledge, Skills, and Abilities:

  • Experience preparing for and hosting customer and regulatory audits and inspections
  • Ability to read, analyze, and interpret complex documents.
  • Ability to respond effectively to the most sensitive inquiries or complaints.
  • Ability to interface effectively with fellow employees, customers, sales and executive leadership.

Education Requirements:

  • BS in a technical / scientific discipline such as BSME, BSEE, Physics or similar technical degree
  • Clear understanding of the elements of ISO 13485 QMS processes, USA FDA part 820 regulations through at least 2 years of progressive experience.
  • Strong Interpersonal and team building skills required.
ATL Technology
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