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Quality Engineer
1 month ago
Position: Quality Engineer (REMOTE right now until onsite is open)
Location: San Diego, CA
Duration: 5+ Months Contract
Total Hours/week: 40.00
Work hours: 9am to 5pm
Remote right now until onsite is open. Must be local and understand that position could return back to the site at anytime.
• 3 Must haves on the resume: Supplier Management, Risk Management and Quality experience
BS or BA or MS in related field required with Min. 5 years of experience (project management experience preferred). Typical degree in Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
Must demonstrate a working understanding of the pertinent Quality Systems Regulations in Supplier Management and Risk Management areas for regulated devices(i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance. Capable of using Microsoft programs and ability to learn other systems. Working knowledge of statistical methods as well as statistical application software. The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).
Responsibility:
Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, Supplier Management, DOE/other process improvement tools, measurement and measurement systems analysis, sampling and control plans.
Applies moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools.
Develops solutions to routine problems of moderate scope.
Follows company procedures and makes basic procedural updates.
Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements.
Support risk management, supplier management, operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
Experience performing supplier qualification and surveys with quality/purchasing/planning team to complete the supplier risk classification and supplier approval list.
Preferred skill set:
1. Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies
2. Statistical Analysis basic knowledge e.g Minitab or Excel
3. Purchasing, Planning and Ordering knowledge
4. Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management)
5. Good understanding of Incoming inspections, COA or COC etc.
6. SAP knowledge
