Compliance Specialist 3

Ipro Networks Pte. Ltd.; Sunnyvale (CA); Hybrid; USD 83,000 - 125,000; Full time

Job summary

IntelliPro is seeking a Compliance Specialist 3 in Sunnyvale, CA for a contract role (12+ months). The position requires the administration of internal and external audits, tracking findings, and driving corrective actions to meet regulatory requirements.

Hybrid onsite work is required, with three days per week in the office. The ideal candidate will have a Bachelor’s degree in engineering or sciences, 2–3 years in medical device compliance, strong project management skills, and familiarity with

Qualifications

• Strong organizational, written and verbal communication skills.
• Experience working with cross-functional teams and diverse stakeholders.
• Ability to prioritize tasks in a deadline-driven environment.

Responsibilities

• Manage external audit administration activities, including coordination, logistics and preparation for external audits.
• Monitor audit findings and ensure timely completion of corrective actions.
• Develop and report external/internal audit metrics to ensure compliance with procedures and commitments.
• Execute governance process for timely reviews of audit findings and reporting to Senior Management.
• Lead and support Audit Module training and process changes per procedures.

Skills

Communication

Organizational skills

Cross-functional collaboration

Education

Bachelor's degree in engineering or sciences

Tools

Project management tools

Job description

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

Primary Function of Position:

• 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).

Roles & 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 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.

Skills, Experience, Education, & Training:

• 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.

About Us:

Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.

IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity athttps://intelliprogroup.com/.

Compensation:

The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.