Senior/Principal Quality Engineer

Major Duties and Responsibilities

Provide Quality Engineering leadership and support for commercial medical device production:

  • Test method assessment and improvement (Test Method Validation, GR&R). Perform data analysis, trending, change control, and deviation support activities.
  • NCR, Complaints and CAPA investigation and review, including: risk analysis, impact assessment, root cause analysis tools, and material dispositions.
  • General quality support for manufacturing operations

Receiving and Incoming Inspection Process Management:

  • Materials handling and transfer management and improvements. This will include development, clinical, and commercial phase-appropriate controls
  • Component specification implementation, revision, and management
  • Provide technical support for routine incoming inspection

Equipment management and validation activities:

  • Establish IQ/OQ, preventive maintenance and calibration requirements
  • Review software risk assessments, validation protocols and reports

Other responsibilities:

  • Clean room and CDA (re-)qualification and periodic monitoring processes (particulate, airflow, viables)
  • Environmental monitoring system management (Rees), updates and validation
  • Support activities related to sterilization management (ETO and E-beam)
  • Support other quality system processes as needed
  • Support audits by regulatory agencies and third parties

Qualifications and Skills

  • Minimum 8 years medical device (Class III preferred) experience with progressive responsibilities
  • Experience in quality systems under applicable cGMP/Quality Systems Regulations (ISO 13485, 21 CFR 820, and MDD/MDR)
  • Demonstrated excellent written and oral communication skills with a track record of strong organizational and interpersonal skills
  • Must be able to define problems, collect data, establish facts, and draw valid conclusionsComputer 
  • Microsoft Office (Word, Excel, PowerPoint), and Statistical Software such as Minitab or JMP
  • Must be familiar with sampling plans such as ANSI Z1.4, Z1.9, and zero acceptance number sampling.
  • Must be familiar with root cause analysis tools (6Ms, 5 whys, fishbone/Ishikawa diagrams, etc.)

Education Requirements

  • Bachelor’s degree in Engineering or related field

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