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QA Engineer – Complaints Specialist

Website Cytiva

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 a hybrid role. The role is a dynamic 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 ISO9001/13485/cGMP environment.
  • Strong written and verbal communication skills in both Swedish and English are essential.

It would be a plus if you also possess previous experience in:

  • Experience handling customer complaints.
  • 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.

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

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, [email protected].

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To be responsible for receiving, analyzing, documenting, and responding to customer complaints in a timely manner.

Perform complaint trend analysis on regular basis to be used at operational reviews, Management Reviews and Complaint Handling Unit (CHU) meetings

Present data for management as required

Manage Product Holds and FMI:s (Field Modification Instruction)

Manage Complaint Handlig Unit teams

Attend customer audits, ensuring understanding of the complaint process

Work with continuous improvements of the complaints process

To approve or reject CAPA/EC plans, Impact assessments and making the final closure of the CAPA.

Initiate, write and establish Customer Quality Letters (CQL)

Support key quality activities and be open to take on additional tasks supporting the overall performance of the Uppsala QA department.

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.

Website Cytiva

To apply for this job please visit www.glassdoor.co.in.


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