What are the responsibilities and job description for the Quality Engineer 2 - Product Transfer position at Sunrise Systems, Inc.?
Only on W2 - No C2C
Job Title: Quality Engineer 2
Duration: 06 months contract.
Location: Glens Falls, NY
Technical Skills
- Minitab
- 3-10 years experience
- Med device or Pharma
- Must come from a regulated industry
Must Have
- Basic statistical analysis skills for interpreting test data.
- Manufacturing Process Validation
- Process Failure Mode Effects Analysis (PFMEA)
- test method development / validation
Nice To Have
- Production transfer experience
- Product / process design
Job Description
- Responsible for supporting production line transfers, including creation of Pfmea, leading component qualification activities, and test method development and validation.
- Ability to integrate into cross functional teams, and ability to find creative solutions to project quality needs, ensuring compliance to quality standards, and product needs.
- Support launch and initial manufacturing operations and assure documentation and procedures are created, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
- Conducts failure analysis, assists in the investigation of manufacturing issues during process development and provides data and input on technical issues and projects.
- BS or BA in chemical, biochemichal, mechanical, electrical or Industrial Engineering, Biological Sciences, Chemistry or other related field required with minimum 2 years of experience (project management experience preferred).
- Must demonstrate a working understanding of the pertinent Quality Systems Regulations (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.
- Effective verbal and written communication skills.
- 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.).