Audit Program Manager - Hybrid (Sunnyvale, CA)

• Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Audit Program Manager on a contract basis to support our Customer's business needs. This role is hybrid in Sunnyvale, CA.

Role Overview

• 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 the organization 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).

Responsibilities

• 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.

Qualifications

• 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.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.