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Quality Assurance Specialist

2 months ago

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

We are seeking a highly motivated and experienced Quality Assurance Engineer to join our team at Enovis. As a key member of our Quality Assurance team, you will play a crucial role in ensuring the quality and reliability of our products and processes.

Key Responsibilities:
  • Develop, implement, and maintain Master Quality Plans to ensure compliance with regulatory requirements.
  • 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