Manufacturing Quality Engineer

Early career opportunity at an established, expanding manufacturer of critical medical device components used in minimally invasive surgical procedures. The manufacturing oriented Quality Engineer will support the implementation of a Quality Management System (QMS) and ensure compliance to ISO13485:2016. 

Responsibilities:

  • Support the maintenance of the QMS, ensuring its continuing suitability, adequacy and effectiveness.
  • Own the Corrective and Preventive Action, Returned Material Authorization, and Nonconforming Material Systems.
  • Manage the Equipment Qualification and Validation System (including IQ, OQ and PQ, etc).
  • Work with Manufacturing and Engineering to draft and execute protocols.
  • Lead the Materials Review Board process where applicable.
  • Perform First Article Inspections with QC Personnel.
  • Where applicable, create and execute Measurement System Analysis (Gage R&R).
  • Work directly with customers to support technical issues and continuous improvement.
  • Support day to day operations to drive Key Process Indicator improvements and business objectives.
  • Supports the Approved Supplier List Evaluations, Reporting and Feedback.
  • Create and edit Standard Operating Procedures, Work Instructions and Forms.
  • Perform Product Quality Inspections as needed.
  • Perform Measuring and Monitoring Equipment Calibration as needed.
  • Perform training as needed.

Qualifications:

  • 2 to 5 years of related experience in medical device quality engineering or manufacturing.
  • Experience in medical component or medical device manufacturing required.
  • Full understanding of a QMS and conformance to ISO13485:2016.
  • Proficient using metrology tools (hand devices, vision systems, microscopes, non-contact devices, profilometer).
  • Basic proficiency in reading drawings and blueprints.
  • Ability to read, listen and communicate effectively in English, both verbally and in writing.
  • Ability to navigate a computer ERP system, in certain modules, and perform data entry, data retrieval.
  • Computer Skills in MS Word, Excel, PowerPoint, Visio are required; QMS software experience is a plus.
  • Experience in customer, registrar or FDA audits/inspections is a plus.
  • The flexibility to take on responsibility and work beyond the scope of essential duties.

Education:

  • BS in a related field.

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