Title: Quality Systems Specialist

Location: Rocklin, CA

Duration: 12 months+

M-F 8am-5pm

Bachelor's Degree

At least 2 years of experience

Risk management/assessment (medical device), validation and data control/integrity experience

Plus: SAP and Trackwise

• The Quality Systems Specialist support site QMS and ensure compliance of the quality system (QS) with regulations relevant to the business, including but not limited to following standards/regulations ISO 13485, IVDR (EU), IVDD (EU), 21 CFR part 20 and part 11, ISO 14971 and GxP.
• Individual represents Quality on cross-functional teams to support business needs and may lead quality initiatives driving positive site Quality culture.
• Prepares QS documentation and reports as needed for routing operations support, site metrics and management review.