Position Title: Quality Engineer 2
Position Number: 358364
Location: Berkeley, CA 94710
Position Type: Temporary
Required Skill Set:
Audit, CAPA, Filing, Healthcare, ISO 13485, Laboratory, Management, Medical device, Quality Engineer, Quality Management
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Quality Engineer 2
Location: Berkeley, CA, 94710
Duration: 12 Months, potential to go permanent
• The Client Laboratory is looking for a Quality Engineer to: Sit on project teams, manage CAPA''s, internal audits, document creation and execution, and assist with QMS updates and/or changes, OOT reviews, supplier management and other general quality role actions.
• The contractor applicant should have a minimum of 3-5 years Quality related working experience at a healthcare company, CLIA lab or CRO.
• Applicant must have a college degree in a hard science.
• Practical understanding of ISO 13485, ISO 15189, CLSI, 21 CFR 820, 42 CFR 495, CAP/CLIA/CLEP, ICH E6, GCLP, EU standards related to IVD.
• Preferably the candidate has managed CAPAs and represented quality on product development teams.
• Previous experience in representing company in 3rd party audits and/or regulatory filings for IVDs a plus.
• The Client Laboratory (SHL) is a CAP accredited CLIA lab with a R&D group and associated support functions.
• The lab is used as a site for clinical trials which require the use of new/novel biomarkers during research testing (safety testing, primary, secondary, research use, inclusion/exclusion testing).
• The lab supports some necessary regulatory filings and customer, regulatory audits each year.
• The SHL is a wholly owned subsidiary of Client Inc.