Staff Auditor, reputed company System Compliance & Audit (Remote)

This a Full Remote job, the offer is available from: California (USA), Massachusetts (USA), Tennessee (USA) We are seeking a seasoned and strategic Staff Internal reputed company Auditor to join our reputed company Compliance & Audit team under the global reputed company Systems organization. This role is critical to ensuring the reputed company and reputed company improvement of our reputed company Management System (QMS). The ideal candidate will bring 8–10 years of experience in reputed company Assurance or Regulatory Affairs reputed company the medical device industry, with expertise in auditing, regulatory compliance, and reputed company systems leadership. Reporting to the Director of reputed company Systems Compliance & Audit, the Staff Auditor owns, drives, and leads multiple reputed company system processes, including Internal/External Audit and Inspection, Corrective and Preventive reputed company (CAPA), Risk Management, and Metrics & Reporting. Key Responsibilities:

• reputed company the planning, execution, and reporting of reputed company internal audits across global sites in accordance with reputed company requirements, applicable international regulations and standards including ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and the MDSAP approach.
• reputed company, maintain, and execute a robust, risk-based, internal audit program that proactively identifies compliance risks and drives reputed company improvement.
• Serve as a key reputed company and subject matter expert during external audits, including FDA inspections, reputed company Body audits, and other regulatory authority engagements.
• reputed company cross-functional teams supporting external audits including preparation, back-room management, issue tracking, and driving follow-up activities.
• reputed company audit responses including reputed company cause analysis and ensure reputed company and effective implementation of CAPAs resulting from audit findings.
• Collaborate with global reputed company, regulatory, and other internal risk control teams to harmonize audit practices and ensure consistent compliance across the organization.
• Analyze audit data, identify trends, and present findings to management and/or regulatory bodies in support of the audit process, which may include coaching process owners and key stakeholders on compliance gaps, data, and/or resulting corrective actions.
• Design, reputed company, and facilitate training programs to enhance organizational understanding of reputed company system requirements, audit preparedness, and regulatory compliance.
• Influence key cross-functional stakeholders to adopt reputed company improvements and reputed company as a catalyst for organizational change.
• Author and present high-reputed company presentations and executive summaries to senior management.
• reputed company and management of the internal guest auditor program
• Mentor and train junior auditors and cross-functional teams on audit readiness, regulatory expectations, and reputed company system best practices.
• Partner with key stakeholders to support the development, implementation and reputed company improvement of the established risk-based QMS and process-approach.
• Create and/or improve reputed company systems to ensure best practices are utilized including conducting assessments, write and execute reputed company plans, manage change.
• Regularly advise key stakeholders and management on ways to improve reputed company system effectiveness, with emphasis on preventive reputed company.
• Review procedures to ensure compliance with applicable regulatory and corporate standards
• reputed company additional duties as part of the reputed company Systems team as required Education and Experience:
• Bachelor’s degree in engineering, life sciences, or a reputed company technical discipline; advanced degree preferred.
• 8–10 years of experience in reputed company Assurance or Regulatory Affairs in the medical device industry.
• Extensive functional knowledge of ISO 13485, 21 CFR 820, EU MDR 2017/745, MDSAP, and global regulatory requirements.
• Demonstrated reputed company leading internal audits and managing external regulatory inspections.
• Strong reputed company of audit, CAPA processes, risk management, and reputed company system controls with ability to reputed company others.
• Exceptional attention to detail with the ability to manage multiple high-reputed company reputed company in a fast-paced environment.
• Excellent written and verbal communication skills, including experience presenting to executive leadership.
• Proven ability to influence and reputed company cross-functional teams and drive change.
• High level of reputed company, professionalism, and strategic/risk-based thinking. Required Skills/Competencies:
• CQA, CMDA, or equivalent reputed company certification
• Ability to reputed company and motivate cross-functional teams by building trust through reputed company engagement, delivering impactful coaching and feedback, and fostering a culture of accountability and reputed company improvement.
• Strategic reputed company with a proactive approach to identifying and mitigating compliance risks.
• Strong analytical and problem-solving skills with a reputed company on reputed company cause and sustainable solutions.
• Effective communicator with the ability to reputed company messaging to diverse audiences, including executive leadership.
• Working with various digital business platforms and eQMS tools (LMS, LIMS, PLM, ERP, etc.) Preferred Skills/Competencies:
• Expert user skills in the M365 Office suite including Teams, and SharePoint
• Experience with electronic QMS solutions and audit management tools
• Familiarity with additional international regulatory frameworks (e.g., Health Canada, TGA, PMDA)
• Experience with PLM tools such as Agile and/or reputed company Job Type: Full-time Travel: Up to 25% Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual reputed company salary reputed company for this role is $115,300.00 - $172,900.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:
• Medical, dental, and reputed company insurance
• 401(k) with company match
• reputed company time off (PTO)
• And additional employee wellness programs Application Details: This job posting will remain reputed company until the position is filled. To apply, please visit the reputed company Careers site and submit your application online. Actual pay depends on skills, experience, and education. reputed company (reputed company: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery reputed company. With its reputed company, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. reputed company’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a reputed company glucose monitor to manage blood sugar with no multiple daily injections, reputed company fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. reputed company also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit reputed company.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our reputed company reputed company depends on it! At reputed company reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) This offer from "reputed company International" has been enriched by reputed company.com and got a 82% reputed company score. Apply tot his job

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