Senior Quality Assurance Engineer

4 days ago

San Diego, California, United States ResMed Full time

Quality Assurance Role Overview

The Quality Assurance function at ResMed plays a vital role in ensuring that our management systems are established to enable business compliance with multiple regulatory frameworks. This includes supporting the design, development, and manufacture of products that meet our customers' quality requirements.

Key Responsibilities

  • Create and build relationships with medical device regulatory bodies in every country to ensure timely registration and meet business needs.
  • Responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements, and development of supplier quality systems.
  • Provide broad business technical support around QA systems and processes to the organization.
  • Lead and implement significant quality projects across the business and create and improve quality and business processes.
  • Develop capability and process development for compliance and continuous improvement.
  • Global responsibility for QMS alignment across global quality systems.
  • Maintenance and security of documentation systems and record keeping.

Requirements

  • Bachelor's Degree in Science, Engineering, or a related discipline.
  • Formal training in Quality Systems audits.
  • Significant audit experience.
  • Knowledge of Quality System Requirements and their practical application in Medical Device Manufacturing and Development.
  • Strong listening, verbal, and written communication skills.
  • Ability to think clearly and critically, assess information, and evidence to make informed, timely decisions.
  • Ability to cooperate and successfully influence others to achieve outcomes.
  • Agility to adapt and respond quickly while being resilient to overcome obstacles.
  • Act as a role model for others within QA and the broader business.
  • Balancing compliance, efficiency, company vision, and goals to produce timely and effective outcomes.
  • Working collaboratively with stakeholders from across the business and geographies to build a quality culture aligned with business goals.

Preferred Qualifications

  • Between 5-8 years of applied professional quality assurance experience, ideally including the medical industry.
  • Solid knowledge and coverage of ISO 13485 and 21 CFR Part 820 requirements.
  • Acting as lead auditor for internal and supplier audits, covering a range of relevant processes and supplier types.
  • Support of relevant certification and regulatory audits, e.g., FDA or TGA.
  • Knowledge and application of Six Sigma and Lead methodologies.

Benefits

ResMed offers a comprehensive benefits package, including 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), and tuition assistance.

Compensation

A reasonable estimate of the current base range for this position is $116,000 - $145,000 USD.

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