Compliance Specialist, Quality Assurance - QA​/QC

Job Title:
Compliance Specialist 3

Location:
Sunnyvale, CA 94043

Type:
Contract (12+ Months, possibility for extension)

Pay Rate: $40.00 hourly on W2.

Schedule:
Hybrid role onsite 3 days per week

• 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 Intuitive Surgical released procedures.
• S/he 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.
• She/he monitors the timely completion of all audit findings related corrective action plans and coordinates the reporting of compliance metrics.
• S/he 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 escap e 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.

• 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.

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