Quality Auditor

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the development and execution of a thorough supplier and internal audit program.

• Generate management reports detailing the status of the audit and CAPA program, evaluating potential business impacts.

• Oversee project management tasks stemming from audit findings and CAPA investigations.

• Collaborate with stakeholders to ensure that findings are addressed effectively and promptly.

• Analyze and verify the completeness of audit observations and CAPA documentation prior to closure.

• Represent ResMed during external audits, which includes preparation, facilitation, and serving as a direct auditee.

• Assist in drafting formal responses to external audits for management's review.

• Suggest and implement ongoing enhancements to the audit system.

• Work in conjunction with QA teams throughout ResMed to synchronize audit, CAPA, and Quality Systems for global implementation.

• Maintain oversight of QA supplier management and monitoring activities.

• Conduct QA projects and other ad hoc tasks as necessary.

• Provide extensive technical assistance for QA systems and processes.

• Support quality initiatives and develop or refine quality and business processes for compliance and continuous improvement.

⛳️ Requirements

• Bachelor’s Degree in Engineering or Science.

• Excellent listening, verbal, and written communication skills.

• Familiarity with Quality Systems in a Medical or similarly regulated industry.

• Moderate experience with audits.

• At least 3 years of professional quality assurance experience, ideally within the medical or a similar regulated industry (preferred).

• Formal training in Quality Systems audits (preferred).

• Training in Six Sigma and experience in analytical problem-solving (preferred).

• Knowledge of ISO13485 and FDA 21 CFR Part 820 requirements (preferred).

• Experience serving as a lead or as an experienced supporting auditor for internal and supplier audits, across various processes and supplier types (preferred).

• Willingness to travel as necessary, approximately 10% of the time.

🏝️ 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 of Paid Time Off (PTO) in the first year.

• 11 paid holidays plus 3 floating days.

• 14 weeks of primary caregiver leave or two weeks of secondary caregiver leave.

• Flexible work arrangements.

• Competitive salaries.

• Opportunities for personal and professional growth.