Quality Engineer, Post Market Surveillance

1 month ago

Other US Location ResMed Full time

Responsibilities:

  • Responsible for Post Market customer quality feedback for Americas region within a Global team, including technical aspect of customer feedback systems and supporting product quality through effective customer communications, identification of emerging issues and accurate customer feedback capture.
  • Partner with local and global product management along with customers to understand customers' experience particularly with respect to technical issues.
  • With manager oversight, review product performance feedback to rapidly react to emerging issues.
  • Monitor incoming complaints and incoming feedback from product managers and field personnel.
  • Review evaluation findings from Tech Services for emerging issues. Provide feedback to customer service, global complaints, design and manufacturing teams, and product managers.
  • Ensure design and manufacturing sites are aware of emerging and persistent issues experienced in region.
  • Develop local tools to assist customer service and technical services.
  • Support non-conforming material system including: ensuring compliance to procedures; performing root cause analyses; performing trend analyses; developing and implementing corrective actions; and improving procedural efficiencies.
  • Perform complaint investigations.
  • Support global regulatory systems and implement regulatory requirements.
  • Perform product, data, and trend analyses to support organizational needs and continuous improvement activities.

Position offered by ResMed Inc.

*Hybrid position*

Minimum Requirements

  • Bachelor's degree or equivalent in Biomedical Engineering or related field of study and
  • 5 years of progressive experience in Biomedical Quality Engineering within FDA regulated environment. Employer will accept a
  • Master's degree or equivalent in Biomedical Engineering or related field of study and
  • 2 years of experience in Biomedical Quality Engineering within FDA regulated environment in lieu of a Bachelor's degree or equivalent and 5 years of progressive experience.

Applicants must have demonstrated experience with the following:

  • providing written communication to customers and internal stakeholders;
  • writing technical customer letters, reports, work instructions, and procedures;
  • reading, interpreting, and implementing regulatory documents, procedures, and reports;
  • reading and interpreting technical documents such as safety rules, operating and maintenance instructions, and procedures;
  • FDA CFR regulatory requirements, related to complaint handling;
  • FDA medwatch reporting requirements;
  • ISO13485;
  • evaluating complaint and post market issues to identify those that require escalation; and
  • supporting quality audits for both internal and external quality audits.

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 accrue three weeks 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.

Base Pay Range for this position: $131,560.00.

#I-DNI

#LI-DNI

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

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