QA Engineer - Complaints Specialist

Posted 21 Hours Ago
Be an Early Applicant
Björkgatan
Entry level
Biotech
The Role
The QA Engineer - Complaints Specialist at Cytiva is responsible for managing customer complaints, queries, documentation requests, investigations, and CAPAs in a dynamic, hybrid role. The role involves coordinating customer feedback, deviation management, and cross-functional collaboration with various departments.
Summary Generated by Built In

Be part of something altogether life-changing!

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The QA Engineer - Complaint Specialist at Cytiva is responsible for independently managing customer complaints, queries, documentation requests, Product Holds, Field Actions, investigations and CAPA:s as required to support the Uppsala site. This position is part of the Quality Assurance Department located in Uppsala and will be an onsite role. As the QA Engineer - Complaint Specialist, you will coordinate the management of customer feedback which includes deviation management, CAPA and response to the customer. This is a highly dynamic role where you will have many cross functional contacts and close cooperation with, for example, product management, manufacturing, QC and R&D.

 What you will do:

  • Responsible for promptly receiving, analyzing, documenting, and addressing customer complaints.
  • Conduct regular complaint trend analysis for operational reviews, management reviews, and Complaint Handling Unit (CHU) meetings.
  • Manage Product Holds and Field Actions Field Modification Instructions (FMI).
  • Work with continuous improvements of the complaints process.
  • Coordinate and manage investigations and CAPAs related to complaints.
  • Represent and present the complaint process during customer audits.

The essential requirements of the job include:

  • Bachelor’s degree or high school diploma.
  • A few years of work experience from similar quality-related roles in the life science industry.
  • Experience working in an ISO9001, ISO13485, and/or cGMP environment.
  • Strong written and verbal communication skills in both Swedish and English are essential.
  • Experience in handling customer complaints and complex investigations.
  • Strong skills in Microsoft Office, specifically in Excel.
  • Creating customer communications/letters.

To be successful in this role, we believe that you are a highly engaged and self-motived individual with excellent networking, interpersonal and communication skills. In addition, we're looking for someone who enjoys problem-solving and troubleshooting, with the ability to work effectively both independently and with others. The ideal candidate should possess a service-oriented mindset, demonstrate unwavering integrity, prioritize quality, and consistently meet deadlines.

Interview and selection will happen continuously and the opening can be filled before last day of application. For questions regarding the role please contact hiring manager Camilla Lindgren, QA Section Manager, camilla.lindgren@cytiva.com.

#LI-HJ2

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The Company
Bengaluru, Karnataka
8,399 Employees
On-site Workplace

What We Do

Cytiva, now with the life sciences business from Pall Corporation, is a global life sciences leader dedicated to helping customers discover and commercialize the next generation of therapeutics. Together, we bring dedicated technical expertise and a broad portfolio of tools and technologies that enable the development, manufacture, and delivery of transformative medicines to patients.

Visit cytiva.com to learn more.

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