Role Description

The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements.

ResMed’s products and our design and manufacturing operations must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. This includes, but is not limited to:

• Food and Drug Administration (FDA) in the United States of America
• Relevant competent authorities in Europe
• Applicable international standards such as ISO 13485
• Requirements prescribed in the Medical Device Single Audit Program (MDSAP)
• European Union Regulations

The role will interact with stakeholders including suppliers, external auditors and internal ResMed departmental managers. Responsibilities include:

• All aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems.
• Providing broad business technical support around QA systems and processes to the organization.
• Supporting and implementing quality projects across the business.
• Creating and improving quality and business processes for compliance and Continuous improvement.

Responsibilities

• Support preparation of and implement a comprehensive supplier and internal audit program that meets the requirements of the business and applicable external regulatory bodies.
• Provide reports to management on the status of the audit and CAPA programs and provide an assessment of the possible resulting business impact.
• Project manage the activities resulting from observations and non-conformances raised during internal audits and as part of CAPA investigations.
• Liaise with stakeholders and drive these findings to effective and timely closure.
• Review and interpret audit observation activities and CAPA evidence for completeness prior to closure.
• Support and represent ResMed in external audit situations through audit preparation, facilitation and acting as a direct auditee when required.
• Recommend opportunities for the continual improvement of the audit system in accordance with best practice.
• Work with corresponding QA teams in other parts of ResMed to ensure that the audit, CAPA and general Quality Systems are aligned.
• Support the maintenance of QA supplier management and ongoing monitoring activities.
• Undertake other QA project and ad hoc activities as required.
• Travel as needed, approximately 10%.

Qualifications

• 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.

Preferred Qualifications

• Minimum 3 years applied professional quality assurance experience ideally including the medical industry or similar regulated industry.
• Formal Training in Quality Systems audits.
• Formal Six Sigma and analytical problem-solving training and application experience.
• Knowledge and coverage of ISO13485 and FDA 21 CFR Part 820 requirements.
• Acting as lead or experienced supporting auditor for internal and supplier audits.

Benefits

• Comprehensive medical, vision, dental, and life insurance.
• AD&D, 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 of employment.
• 11 paid holidays plus 3 floating days.
• 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.

Salary Range

A reasonable estimate of the current salary range for this position is: $68,000 to $102,000.

Company Description

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.