Quality Auditor

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $68k - $102k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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ResMed

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1989

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Post-IPO Debt on 2019-07

Healthcare • Manufacturing • Healthcare Insurance

ResMed is a global leader in sleep technology and respiratory care, focused on improving out-of-hospital care to enhance the health and quality of life for individuals with chronic diseases. With over 30 years of innovation, ResMed develops life-changing technology and provides software platforms that support medical professionals and caregivers in helping patients manage their health from home or in preferred care settings. The company is committed to diversity and inclusion, supporting a wide range of professionals in building meaningful careers, and shaping the future of connected health care with the goal of impacting 250 million lives worldwide.

📋 Description

• Support preparation and implementation of a comprehensive supplier and internal audit program • Provide management reports on audit and CAPA program status and assess possible business impact • Project manage activities resulting from audit observations and CAPA investigations • Liaise with stakeholders and drive findings to effective and timely closure • Review and interpret audit observations and CAPA evidence for completeness before closure • Support and represent ResMed in external audits, including preparation, facilitation, and acting as a direct auditee • Support preparation of formal responses to external audits for management review • Recommend and implement continual improvements to the audit system • Collaborate with QA teams across ResMed to align audit, CAPA, and Quality Systems for global deployment • Maintain QA supplier management and monitoring activities • Undertake QA projects and ad hoc activities • Provide broad technical support for QA systems and processes • Support quality projects and create or improve quality and business processes for compliance and continuous improvement

🎯 Requirements

• Bachelor Degree in Engineering or Science • Strong listening, verbal and written communication skills • Experience with Quality Systems within a Medical or similarly regulated industry • Moderate audit experience • Minimum 3 years applied professional quality assurance experience ideally including the medical industry or similar regulated industry (preferred) • Formal Training in Quality Systems audits (preferred) • Formal Six Sigma and analytical problem-solving training and application experience (preferred) • Knowledge and coverage of ISO13485 and FDA 21 CFR Part 820 requirements (preferred) • Experience acting as lead or experienced supporting auditor for internal and supplier audits, covering a range of relevant processes and supplier types (preferred) • Ability to travel as needed, approximately 10%

🏖️ Benefits

• Comprehensive medical, vision, dental, and life insurance • AD&D insurance • Short-term and long-term disability insurance • Sleep care management • Health Savings Account (HSA) • Flexible Spending Account (FSA) • Commuter benefits • 401(k) • Employee Stock Purchase Plan (ESPP) • Employee Assistance Program (EAP) • Tuition assistance • Three weeks Paid Time Off (PTO) in the first year • 11 paid holidays plus 3 floating days • 14 weeks of primary caregiver or two weeks of secondary caregiver leave • Flexible work arrangements • Competitive salaries • Opportunities for personal and professional growth