What are the responsibilities and job description for the Quality Engineer position at Stellar Consulting Solutions, LLC?
Title : Validation QE II
Primary Work Location : San Diego, CA, USA (100% onsite 5 days a week)
Duration : Contract 12-18 Months with possible extension
Compensation : $48.75 / hr. (W2, fixed, all-inclusive without benefits)
Job Summary :
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies. Successful performance requires close work with quality management, operations, suppliers and / or BD associates to assure compliance with all BD quality policies, procedures, and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I / II / II products. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ, OQ, PQ) and Nonconformance management 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.
Job Responsibilities : (Primary Duties, Roles, and / or Authorities)
- Experience performing equipment and process validation studies such as writing and / or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities.
- Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners.
- Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment.
- Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.
- Review and update FMEA or Risk documents as needed for validation activity for the site
- Perform additional duties to ensure business continuity during the relocation of the manufacturing processes into new area. Duties include but are not limited to execution of QA inspection to support dual operations, review and approval of documents such as batch records to support finished product release.
Education and Experience :
Knowledge and Skills :
Salary : $49
