Quality Engineer

  • Regenesis Biomedical
  • Scottsdale, AZ, United States
Full Time QA-Quality Control

Job Description

POSITION SUMMARY

The primary responsibility of this position is to support all aspects of the Quality Management System, with a primary focus on design control, manufacturing controls, nonconforming materials, supplier evaluations, auditing and training. This position will also support other areas of the Quality Assurance department and additional tasks determined by management.

 ESSENTIAL DUTIES & RESPONSIBILITIES 

  • Assist in the implementation of corporate policies and procedures related to quality, process development and ISO 13485/FDA QSR compliance
  • Support design control process in the planning, design, preparation, execution, reporting, and analysis of design verification testing; and process validations to approve equipment, processes, and software
  • Verify quality of manufacturing processes; perform environmental monitoring and periodic ESD verification testing; ensure equipment is calibrated
  • Perform new supplier evaluations, monitor existing suppliers, issue corrective action requests and perform periodic re-evaluations
  • Oversee nonconforming materials, participate in Material Review Board evaluations and assign disposition of nonconforming materials
  • Ensure required training is identified, completed and documented
  • Assist in the completion of corrective/preventive actions (CAPAs); perform root cause analysis to determine the true cause of nonconformities
  • Perform audits, participate in FDA inspections and ISO 13485 audits
  • Provide quality metrics compilation and reporting
  • Other such duties as determined by management

 CORE COMPETENCIES / KNOWLEDGE & SKILL REQUIREMENTS

  • Quality background in design control, analysis, problem-solving and statistical techniques
  • Previous inspection / manufacturing experience
  • Previous auditing experience
  • Knowledgeable about FDA QSR, ISO 13485 and OSHA
  • Broad project and process knowledge, including medical devices
  • Self-starter and a team player; able to work with minimum supervision
  • Strong oral and written communication skills
  • Computer proficiency in Excel, Word, Power Point, Visio and ERP systems

 EDUCATION, EXPERIENCE & TRAINING REQUIRED

 BS/BA in science or technical field and 3-5 years quality assurance experience

 

Regenesis offers competitive pay, health insurance benefits, matching 401k and a generous paid time off plan.       

Regenesis Biomedical is an Equal Opportunity/Affirmative Action Employer

Minorities/Women/Disabled/Veterans

 

Occupations

Production Quality Assurance