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Engr 2, Quality
Job Description
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: []
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
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