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Quality Engineer I

CAPRICOR THERAPEUTICS, INC
San Diego, CA
  • Posted: 24 days ago
  • Full-Time
Job Description

Position: Quality Engineer I

We are seeking a highly motivated individual to join the Quality Engineering team as a Quality Engineer I. The successful candidate will serve as an essential role in supporting quality engineering and facility engineering functions. This includes equipment/systems qualifications, maintaining the calibration and preventive maintenance quality systems, developing risk assessments, developing and revising protocols and standard operating procedures and other engineering functions.

Responsibilities:

  • Quality oversight of Commissioning, Qualification and Validation (CQV)
  • Working collaboratively with other site functions
  • Aligning on change control requirements to manage the requested change in consultation with company standards
  • Assist with periodic reviews, creation and revision of procedures
  • Supporting corporate’s quality system management with eQMS implementation, measurement and control strategies
  • Supporting regulatory inspections and audits
  • Conducting risk assessments for critical equipment, utilities, systems and processes
  • Supporting vendor qualification and compliance audits
  • Reviewing and approving proposed changed to systems and procedures, as appropriate
  • Reviewing and approving protocols and summary reports
  • Tracking, reviewing and reporting metric information for use in continuous improvement of areas of responsibility
  • Supporting continuous improvement initiatives and projects within the company’s quality organization

Requirements:

  • Master’s Degree and 0+ years’ experience in pharmaceutical or FDA environment OR Bachelor’s Degree and 2+ years' experience in pharmaceutical or FDA environment OR AA Degree and 4+ years’ experience in pharmaceutical or FDA environment
  • Extensive knowledge of cGMPs
  • Working knowledge of basic quality systems, calibration, preventive maintenance, industry specific quality systems such as cGMP CFR Part 210, 211, etc.
  • Working knowledge and experience of validation program in a regulated environment such as pharmaceutical, medical device or aerospace industry
  • Strong oral and written communication and presentation skills
  • Experience working on cross-functional teams
  • Experience in technical writing of SOPs, protocols and other controlled documents
  • Experience with Change Control practices and strategies
  • Proficient in MS Word, Excel, Power Point, Teams and other applications
  • General knowledge of aseptic manufacturing processes




CAPRICOR THERAPEUTICS, INC

Address

San Diego, CA
USA

Industry

Manufacturing

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