Senior Manager - QA Custom Hardware

Posted 9 Days Ago
Be an Early Applicant
Björkgatan
5-7 Years Experience
Biotech
The Role
The Senior Manager QA for Custom Engineering & SCO leads, coordinates, and prioritizes quality management processes within the assigned site to ensure successful operations. Responsibilities include overseeing deliveries, internal audits, training, documentation, complaints, and driving a strong Quality Culture through engagement and empowerment.
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 Senior Manager QA for Custom Engineering & SCO (Standard and Custom Operations) Sweden, independently leads, coordinates and prioritizes the work within the assigned site/s to ensure successful management of the QMS and associates processes.

The role is responsible for ensuring that the Custom Engineering Sweden team executes on deliveries, internal audits, QMS training, QMS documentation, complaints, NC/CAPA, product holds and field actions. Ensures compliance of the processes and drives a strong Quality Culture by engagement, empowerment, and inclusiveness.

This position is part of the QA Custom Hardware department located in Uppsala, Sweden and will be onsite. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Be responsible for engaging strong intra departmental and cross-functional/organizational relationships to drive compliance and ensuring product quality
  • Be the QA representative in project steering committees as agreed with QA Director
  • Lead, coordinate, prioritize and follow-up the work within the team.
  • Engage, coach and develop the personnel.
  • Set goals for the team and follow up on completion.
  • Drive internal improvement work to assure continuous improvements.
  • Support key quality activities and be open to take on additional tasks supporting the overall performance of the QA Department

Who you are:

  • Bachelor’s degree preferably in a science or engineering discipline
  • A minimum of 5 years of experience in the Quality Assurance field
  • Experience of working as a manager within Quality Assurance/Quality Control 
  • Comprehensive understanding of ISO 9001 requirements.
  • Experienced in continuous improvement methodologies & tools.
  • Experienced in leading external audits, including customer communications.
  • Excellent organizational, presentation, meeting facilitation and technical writing skills

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

  • Knowledge and awareness of the methods and techniques of Quality Control in the manufacturing industry.
  • Technical knowledge of systems/devices used in the biopharma field.
  • Fluency in Swedish both written and verbal communication

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
Marlborough, MA
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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