This position is responsible for administering aspects of the Quality Management System within the company's defined policies, procedures and regulatory requirements to satisfy FDA QSR, 98/79/EC IVDD and ISO 13485 requirements.
2. Scope and Impact
Has responsibility within the RA/QA department. Participates in ensuring company-wide awareness of diaDexus quality and regulatory programs and maintains alignment to such programs. The job involves close interaction with staff on technical issues with the products and on the mechanics of the Quality System, and interfaces with the entire organization and third-party auditor/inspectors.
3. Essential Functions
Administer the diaDexus Audit Program (internal/supplier) and participates in internal, supplier, and third-party audits and regulatory inspections by federal, state and international agencies at diaDexus and at contractors/distributors as needed. As needed, planning, conducting, and issuing reports through closure.
Develop and conducts diaDexus auditor training (and certification as needed) and responsible for monitoring ongoing performance of diaDexus and contracted auditor.
Participate in regulatory activities as needed to achieve successful and timely company/product registrations, submissions, approvals, certifications, etc.
Support corrective and preventative actions sub-systems (e.g. Nonconforming Reports, CAPA) as needed. Ensures input from various sources are addressed through effective root cause analysis and troubleshooting investigations in resolving and precluding product, service and quality system failures and inefficiencies. Reviews for closure action plans, completes appropriate forms, performs effectiveness checks, prepares documentation as needed, updates log.
Support Customer Complaint and Feedback Handling function to ensure proper and timely complaint handling. Including as appropriate, review and reporting requirements of the U.S./EU Medical Device Reporting regulations (MDR and MDV) and the US/EU Corrective Action review and reporting requirements, root cause identification, customer satisfaction and complaint closure. Monitors complaint review and support/performs trend analysis.
Update documents for compliance with applicable regulatory and diaDexus requirements through the Document Change Order process.
Participate in new employee training (e.g. cGMP, CGLP, SOP), and annual refresher training. Assist with coordination of the Validation Master Plan, assists in drafting validation protocols. Ensure accuracy and compliance of executed protocols. As needed, may assist with execution of validation and writing reports.
4. Education/Experience Required
BA/BA or equivalent experience preferred
Minimum of 5-8 years of experience in biotechnology, medical devices, regulatored field
RAB Certified Lead Assessor, CQA, or equivalent preferred
343 Oyster Point Boulevard
South San Francisco, CA 94080