Post Market Quality Analyst

Sunnyvale, CA

Posted: 09/18/2019 Position Categories: Administrative

Executes Quality Systems and Regulatory Compliance requirements in conjunction with Company, Business and Regulatory requirements. Coordinates Quality System / Regulatory Compliance (QS/RC) interactions, requirements and compliance activities interfacing with Technical Service, Technical Support and other customer support teams.  Responsible for maintaining customer-facing and field activities including complaint handling, product investigations and field actions (corrections, recalls and event reporting) activities.

ESSENTIAL JOB RESPONSIBILITIES:

  • Support integration of the Post Market Process into all facets of the QMS to include management controls, Complaint Handling, Corrective and Preventive Actions, and Risk Management.
  • Support processing Customer Complaints in a compliant and timely manner.
  • Assist in the reporting of all Reportable events to the applicable Regulatory Agency.
  • Provide QS/RC input on continuous improvement of customer facing systems
  • Support changes to QS/RC processes through timely analysis and completion of field reports, service requests and customer complaints
  • Support Field Action Coordinator with any tasks necessary to support field actions and/or field corrections.
  • Partner with Quality Systems to continuously evaluate and improve internal compliance systems
  • Continuously review requirements and practices in customer-facing responsibilities to ensure compliance to business, customer and regulatory needs
  • Support continuous improvement of the Cepheid quality system meeting both operational quality and regulatory requirements.
  • Ensure compliance to 21CFR820, ISO 13485, and other quality systems regulations and regulatory standards, as applicable.
  • Partner with marketing and distributors to ensure compliance with contractual requirements, especially related to product performance and patient safety.
  • Suggest significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas.
  • Identify potential problems, including ambiguous situations, by actively reviewing and analyzing internal and external factors. Assess the potential impact and/or applicability to other related areas. Recommend corrective action to mitigate problem and preventive action to ensure there is no recurrence.
  • Prepare formal written reports/documents for distribution within work unit and regions.

 

Education or Experience (in years): 

  • Bachelor’s degree or equivalent in Molecular Biology, Biology, Chemistry or related scientific discipline with at least 2 years of experience in a fast paced regulatory/compliance/quality team ideally in a medical environment
  • Understanding of quality and QS/RC compliance requirements in relationship to product performance and customer expectation.

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.

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