QT
Qool Therapeutics

Medical Device Quality Engineer

Job title

Quality Engineer

Reports to

Director of QA/RA

Department

Quality Assurance

FLSA Status

Exempt

Work Hours

Full time permanent

Job Purpose

This position has primary responsibilities in quality assurance and regulatory compliance.

Essential Job Functions

  • Complete test plans and RMF checklists for various standards in preparation for certification.
  • Identify gaps in compliance and implement solutions to address gaps.
  • Work directly with suppliers to plan, prepare for, and execute various verification testing.
  • Provide documentation support for various design control documentation.
  • Support CAPA and NCMR processes through investigation, implementation, and monitoring of effectiveness as required.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Monitor product quality through inspection, testing, and auditing.
  • May be responsible for creating risk analyses and FMEAs.
  • May draft or perform process validations as required by the Master Validation Plan.
  • Other duties as assigned.
  • Responsible for following the company’s quality management system and all applicable laws and regulations.

Qualifications

  • Bachelor’s degree in engineering, life sciences or other applicable degree; Master’s degree preferred.
  • Must have at least 5 years of experience in medical device quality assurance.
  • Certification such as ASQ CQE preferred.
  • Must have experience:
  • IEC 60601-1 Electrical Safety
  • IEC 60601-1-2 EMC
  • ISO 14971 Risk Management
  • 62366 and 60601-1-6 Usability Engineering.
  • 62304 Software Life Cycle experience is preferred.
  • Good working knowledge of quality systems and specific regulations (e.g., 21 CFR 820, ISO 13485).
  • Proficiency with MS Office (Word, Excel, and PowerPoint) required.
  • Knowledge and experience with eQMS software or other office/engineering software preferable.
  • Must be organized, a strong communicator, detail-oriented, and cooperative in a fast-paced environment.

Physical Demands

  • Repetitive computer use required.
  • Some travel (up to 25%) may be required.

Safety Requirements

  • Follow lab and office safety standards
  • Use personal protective equipment (PPE) as required in various work environments and with certain materials and equipment. Employees must use the appropriate PPE for the environment and/or task, e.g. laboratory, handling cryogenic materials, etc.

Job Type: Full-time

Pay: $90,000.00 - $110,000.00 per year

Benefits:

  • Dental Insurance
  • Health Insurance
  • Life Insurance
  • Paid Time Off
  • Vision Insurance

Schedule:

  • Monday to Friday

COVID-19 considerations:
Our employees work remotely as needed.

Experience:

  • 60601-1: 2 years (Preferred)
  • ISO 13485: 3 years (Required)

Education:

  • Bachelor's (Required)

Location:

  • Mountain View, CA 94043 (Required)

Work authorization:

  • United States (Required)

Work Location:

  • One location

Company's website:

  • qooltherapeutics.com

Benefit Conditions:

  • Only full-time employees eligible

Work Remotely:

  • Temporarily due to COVID-19

Please mention that you come from TestForThem when applying for this job.

Posted 2 months ago

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