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Quality Assurance Engineer

Sylmar, CA

Order: 65461

We are currently looking for a Quality Assurance Engineer to work for a Medical Device Company in the Sylmar area. The Quality Engineer is responsible for assisting in ensuring company compliance to include: SOPs, Policies, ISO 9001, AS 9100 and customer requirements, including the training of those documents. 

Essential Functions

  • Assist in root cause investigations, communicate findings and recommendations when quality issues do arise

  • Plans, schedules and performs quality system audits. Changes to pertinent regulations, audit observations and changes to existing products and processes.

  • Measures and analyzes audit and QMS data and leads continual improvement initiatives

  • Directs quality assurance activities for product introductions and validations.

  • Provides quality sustaining support for released production parts and activities.

  • Manage and perform activities associated with CAPA, Complaints, Non-Conforming Materials, Risk Management, Sterilization Validation, Packaging, Biocompatibility Statistical Analysis, Inspection and Calibration.

  • Assist with Document Control, Change Control, Sterilization Validation, Inspection/Calibration, CAPA and other Quality Systems tracking/trending.

  • Assemble reports, amendments, supplement, and letters to file to support Quality System compliance.

  • Develop and establish SOP's according to regulatory requirements

  • Lead others in the quality department through implementation and maintenance of the company quality system

  • Other duties as needed

 

Top Skills

  • Strong technical writing skills, the ability to communicate effectively with management, technical teams, and customers

  • Metrology expertise, CMM techniques and language (PCDMIS), Romer Arm, etc.

  • Project management lean six sigma and leadership skills

  • Skilled in risk assessment and analysis, i.e. flowcharts, pfmea, control plans, CAPA processing

  • Strong fundamental understanding of ISO 13485 requirements and/or ISO 9001

Qualifications

  • Bachelor’s Degree in a science, Industrial Engineering, or related field

  • 5 + years with quality and/or inspection processes

  • Proficient with Microsoft Office and Minitab

  • Six Sigma Black Belt certification is a plus

 

 

Evergent Group celebrates diversity and has an active diversity policy. Evergent Group is a proudly certified Disabled Veteran Business Enterprise and Minority Business Enterprise.

 

Qualified candidates with criminal histories, are considered in a manner that is consistent with local, state and federal laws.