Engr 2, Quality
Lancesoft
Irvine, CA
Project Party: Job Description:
Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant. Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. Conducts complaint investigations and complaint Engineering Evaluations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.Perform label change reviews and their product impact assessment.BS or BA in related field required with 2-5 years of experience, or MS with no experience required (project management experience preferred). Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field. 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.).
Bill rate: ***
General Expectations:
1. Excellent communication skills working with cross functional teams.
2. Review and approve product labeling changes and product impact assessments.
3. Perform root cause failure mode assessment for electronic devices.
4. Execute Engineering Evaluations for complaint closure.
5. Onsite work
6. Other product sustaining activities and qualifications mentioned in job description.
Shift: []
Start: []
About the Company
Lancesoft
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.