Compliance Jobs 2026 (Now Hiring) – Smart Auto Apply
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Compliance Specialist 3
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Overview
Job Description
- 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
- 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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