Post Market Quality Analyst
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.