Senior Quality Assurance Specialist – Post Market Surveillance (PMS)

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At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

The Senior Quality Assurance Analyst, Post Market Surveillance for Beckman Coulter Diagnostics is a critical role in supporting the Global Process Owner (GPO) of Service, Install, Complaints and Vigilance. This position will be responsible for facilitating procedural updates, assisting in compliance activities, and supporting both internal and external audits.

You will be part of the Post Market Surveillance organization located in Co Clare, Ireland and will be on-site. You will report to the GPO of Service, Install, Complaints and Vigilance who is responsible for maintaining and overseeing of the global Service, Install, Complaints and Vigilance processes to ensure compliance with all applicable global regulatory requirements. If you thrive in a multifunctional role and want to work to build a world-class post market surveillance organization—read on.

The Senior Quality Assurance Specialist – Post Market Surveillance (PMS) will be responsible for leading and managing the post-market surveillance activities related to the Service/Install and Complaint/Vigilance processes to ensure continued compliance with regulatory requirements and company policies. This position may support global elements of the QMS and lead or participate in continual improvement initiatives.
The ideal candidate will have strong analytical skills, a deep understanding of regulatory requirements, and extensive experience in the medical device industry.

In this role, you will have the opportunity to:

• Being responsible for ensuring compliance with Complaint/Vigilance and Service/Installation processes.
• Collaborating with cross functional teams in resolving issues, completing investigations and maintaining compliance
• Being responsible for QA reviewing and approving of the following types of documents: Procedures, Corrective and Preventative Actions (CAPA).
• Reviewing various system records for assignment, compliance, and closure
• Providing administrative support of electronic systems
• Reviewing procedures, policies and other instructional documents relating to Complaint/Vigilance and Service/Installation processes to ensure compliance with company policy with local and international regulatory requirements
• Monitoring and reporting on trending metrics
• Actively participating in continuous improvement ideas, initiating, and implementing
• Participating in internal, regulatory and customer audits
• Training personnel on the processes.

The essential requirements of the job include:

• Bachelor's degree with 5+ years or master’s with 3+ years or Doctoral degree with 0-2 years.
• Ability to develop relationships and mentor business users on process requirements
• Excellent time management, communication, and organizational skills along with a proven track record to multi-task required
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

• Work may be independent/flexible, so an ability to manage time and productivity to meet department metrics and a high level of personal integrity is required.
• Experience in Post Market Surveillance/QA preferred.
• Knowledge of 21CFR820 FDA Quality System Regulation (QSR), 21CFR803 Medical Device Reporting, SFDA regulation and vigilance reporting.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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