Quality Engineer II

sgs-job-4108

Engineering
 California
validation
quality engineering
process validation
equipment qualification
PFMEA
risk assessment
change control
GMP
ISO 13485
21 CFR Part 820
statistical analysis
documentation (protocols & reports)

Contract - 06 Months

Location : San Diego, CA 92121 Quality Engineer II is responsible for supporting validation activities, risk management, and quality system compliance in a regulated medical device environment. The role involves authoring and reviewing validation protocols, performing risk assessments, supporting change control, and ensuring compliance with GMP, ISO, and FDA requirements.

Job Responsibilities:

  • • Author and execute validation protocols and reports for equipment, processes, cleaning, analytical methods, facilities, and utilities • Develop and maintain master validation plans and validation strategies based on risk-based approaches • Perform process risk assessments including PFMEA, Non-Conformance Events (NCEs), and planned deviations (PDVs) • Review and assess change controls for validation impact and compliance requirements • Support equipment, process, and facility qualification activities in accordance with GMP and regulatory standards • Participate in new product introduction (NPI) and sustaining engineering projects • Collaborate with cross-functional teams including Manufacturing, Operations, and Regulatory Affairs • Support Material Review Board (MRB) and Production Response Team (PRT) activities • Ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11 requirements • Maintain validation records, documentation, and quality system deliverables • Support statistical analysis, acceptance sampling, and process capability studies • Provide status updates, escalate risks, and support continuous improvement initiatives • Assist in development and updates of quality procedures and controlled documents

Skills:

  • 3+ years (minimum 2+ acceptable) of experience in Quality Engineering within medical device, biotech, diagnostics, or pharmaceutical industry
  • Strong experience in validation (process, equipment, cleaning, analytical, facilities/utilities)
  • Hands-on experience authoring validation protocols and reports
  • Strong knowledge of PFMEA, risk assessment, and change control processes
  • Understanding of GMP, FDA regulations, ISO 13485, ISO 14971, and 21 CFR Part 820
  • Experience working with electronic document management systems
  • Strong analytical and problem-solving skills with attention to detail
  • Proficiency in MS Word, Excel, and Project
  • Strong communication and cross-functional collaboration skills

Education/Experience:

  • bachelor’s degree in science or engineering required

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