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Quality Specialist II
Ref No.: 18-13210
Location: San Diego, California
This position supports Quality Assurance activities related to quality system compliance and continuous improvement. The ideal candidate will have a Quality Assurance background in an in vitro diagnostic or molecular reagent company and/or a product development background in molecular biology products or molecular diagnostic products company utilizing nucleic acid technology (e.g., PCR, sequencing, etc.) is a plus.
Support the document control program as well as suggest and implement improvements to existing process.
Work with management to improve quality system policies and procedures.
Write and/or review documents.
Perform trending analysis (Quality Metrics) on an as needed basis, including using statistical process control methods.
Perform other duties as assigned.

Excellent problem solving and analytical skills/ability to exercise independent judgement.
Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
Works under limited supervision.
Experience with ISO 13485 and CFR 820.
An understanding of GDP, FDA Quality System Regulations, CLIA and/or ISO Standards (ISO 13485 and ISO 14971) is a plus.