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Quality Assurance Specialist

2 months ago

Chula Vista, California, United States DJO Global Full time
Job Title: Quality Assurance Engineer

We are seeking a highly motivated and experienced Quality Assurance Engineer to join our team. The successful candidate will be responsible for implementing and overseeing quality assurance activities at our manufacturing location.

Key Responsibilities:
  • Develop, implement, and maintain Master Quality Plan
  • Facilitate quality improvement through data collection, control charting, and experimental design techniques
  • Participate in the Master Validation Plan (IQ, OQ, PQ) for validation processes
  • Lead continual improvement activities such as 5S and Kaizen lean methods
  • Develop and conduct training programs for quality awareness
  • Interface with Engineering and Operations to ensure product changes align with approved data
  • Support Quality Inspectors/Techs to ensure compliance with the quality management system
  • Conduct audits and analyze failure, corrective, and preventive actions
  • Create and maintain company quality documentation
  • Organize and manage receiving/outgoing quality functions
  • Drive continuous improvements and manage Nonconformances
  • Resolve customer and internal quality concerns using problem-solving techniques
  • Work on DOE projects and manage Gage R&R, SPC, and Capability requirements
  • Participate in Launch and Current Production Engineering Changes
  • Support Lean initiatives and review of Daily and Weekly Quality performance Scorecards
  • Ensure a safe work environment and compliance with safety and environmental regulations
  • Evaluate nonconforming material and recommend updates to quality standards
  • Assure product compliance with internal or external specifications and standards
  • Analyze trends in device failures and lead root cause analysis
  • Support Manufacturing and Operations to resolve quality or compliance issues
  • Serve as a subject matter expert for quality in audits
  • Author procedures and work instructions for the quality system
  • Conduct internal audits and support complex special projects as assigned
Requirements:
  • Bachelor's degree in science or engineering and 5 plus years of applicable experience (CQA or CQE certification preferred)
  • Bilingual Spanish/English preferred
  • Certification to perform audits is required (certification may be obtained through successful completion of an auditor course or CQA, or on-the-job training by another qualified internal auditor)
  • Proficiency in Medical Device engineering standards and concepts, along with knowledge of FDA/GMP, CMDR, MDR, MDSAP, and ISO quality standards
  • Basic knowledge of manufacturing processes (and associated tools, instruments, and test equipment) including inspection, machine shop technology, polish/grind, and clean room technology
  • Proficient in Microsoft Word (or equivalent word processing software) and Excel (or equivalent spreadsheet software)
  • Statistical analysis and database searches
  • Competent working knowledge of US and International quality system regulations
  • Proven project management skills
Travel Requirements:

Up to 10%

Desired Characteristics:
  • Preferred knowledge of the following software packages: Microsoft, Minitab, Oracle R12, Agile PLM
  • Prefer CQE, Lean, or 6 Sigma Certification
  • Detail oriented and analytical
Physical Requirements:
  • Ability to sit/stand for long periods of time
  • Ability to lift/pull/carry up to 25lbs