Our client, a Medical Technology company, is looking for a Compliance Specialist 3 for their Sunnyvale, CA/Hybrid location.
Responsibilities:
Audit Program Manager performs the day-to-day administration of all processes related to internal and external audit.
This role ensures that all Quality audit activities are being performed per client released procedures.
Manager will ensure effective closure of internal and external audit findings, by working with cross functional and varying level of departments/business partners to ensure comprehension, development, and execution of corrective/preventive action and evaluation of effectiveness checks.
Manager monitors the timely completion of all audit findings related corrective action plans and coordinates the reporting of compliance metrics.
Manager will support the implementation and continuous improvement of the quality and regulatory compliance programs (including inspection readiness programs).
Manage external audit administration activities, including coordination, logistics and preparation for external audits
Monitor the audit finding related activities as a result of internal and external audits to ensure timely completion
Develop and facilitate the reporting of external and internal audit related metrics to ensure compliance to internal procedure and external commitments
Execute the governance process to ensure timely and effective reviews of audit findings and visibility to Senior Management
Promotes a culture of compliance to regulations, standards, and procedures and risk management through monitoring and reporting process
Serve as key liaison for engineering change orders/QMS project support
Lead and refine the internal audit module, including but not limited to: trouble shooting issues as needed and know when to escalate to IT, partnering with Training LMS Administrator to develop, improve and administer Audit Module training, provide group or individual training, ensure process changes per documented procedures in Audit Module
Monitors and audits adherence to corporate policies as directed and investigate any violations, including coordinating investigations, audits, conducting interviews, and preparing reports
Lead other audit management related projects as required
Requirements:
Minimum Bachelor's Degree or equivalent years of experience, in Engineering, physical or biological science or other technical field.
A minimum of 2-3 years of experience in compliance role in the medical device industry
A working knowledge of project management tools and techniques
Knowledge of EU-MDR, ISO 13485:2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, , Health Canada, and other international regulatory requirements
Certified Quality Auditor/ISO lead Auditor Certification desired
Demonstrated ability to effectively work with cross-functional/cross-plant project teams and work effectively with a variety of work groups
Experience interpreting, and providing guidance on domestic and international regulations as applicable to the quality management system
Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
Strong interpersonal skills - ability to work closely with people at all levels within the ISI organization and facilitate the implementation of corrective action.