Senior Engineer, QA Engineering

Senior Engineer, QA Engineering

Location: San Diego, CA, United States

Time Type: Full time

Posted On: Posted 6 Days Ago

The primary role of the 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 that meet our customer’s quality requirements. Key deliverables include creating and building relationships with medical device regulatory bodies in every country, ensuring timely registration to meet business needs, and being responsible for all aspects of auditing to ensure regulation compliance, quality best practices, process improvements, and development of supplier quality systems. Provides broad business technical support around QA systems and processes to the organization. Leads and implements significant quality projects across the business and also creates and improves quality and business processes. 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.

Must be located within a 1-2 hour drive of the San Diego office.

Responsibilities:

• Prepare and implement a comprehensive internal and supplier audit program that meets the requirements of the business and applicable external regulatory bodies.
• Provide reports to management on the status of the audit program and provide an assessment of the possible resulting business impact.
• Project manage the activities resulting from observations and non-conformances raised during internal audits, liaise with stakeholders, and drive these findings to effective and timely closure.
• Review and interpret audit observation activities and 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, including preparing formal responses to external audits ready for management review prior to submission.
• Recommend opportunities for the continual improvement of the audit system in accordance with best practices and individual analysis of specific ResMed needs and lead implementation.
• Work with corresponding QA teams in other parts of ResMed to ensure that the audit systems are aligned and suitable for global deployment where appropriate.
• Support the maintenance of QA supplier management and ongoing monitoring activities to facilitate effective supply chain management and ensure external regulatory compliance requirements are met.
• Undertake other QA project activities as required.

Qualifications and Experience:

Required:

• Bachelor Degree in Science, Engineering or 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, including compliance with FDA, EU MDR, and ISO (ISO 13485) and specific Market Regulatory requirements.
• 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.
• Address audit issues and raise the profile and reinforce the value of the audit program through effective collaboration with business stakeholders.
• Managing conflicting priorities of self and stakeholders to deliver on agreed milestones.
• Maintaining solid knowledge of ResMed’s QMS and staying current in industry requirements and best practices.

Preferred:

• Between 5-8 years applied professional quality assurance experience ideally including the medical industry.
• Significant audit experience, including:
  • Solid knowledge and coverage of ISO13485 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.

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, 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. Employees receive fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.

Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills. A reasonable estimate of the current base range for this position is: $116,000 - $145,000 USD .

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. Where a culture driven by excellence helps you not only meet your goals but also create new ones. 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.

ResMed is an equal opportunity employer and provides equal opportunity in employment for all qualified persons, without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

(US/Canada only) ResMed is an equal opportunity/affirmative action employer. ResMed is a smoke-free workplace.

We are a 2024 Circle Back Initiative Employer – we commit to respond to every applicant!