Manager QA Operations

Job title:

Manager QA Operations

Company

Danaher

Job description

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At HemoCue, one of 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we’ve been advancing what’s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count.Learn about the which makes everything possible.The Manager QA Operations is responsible for implementing quality assurance processes and supporting Hemocue’s Operations teams to ensure safety and quality standards are met for all products.This position reports to the Sr Director RAQA and is part of the RAQA team located at Hemocue, Ängelholm, Sweden and will be an on-site role.In this role, you will have the opportunity to:

• Manage activities, resources and personnel within the QA Operations team.
• RA/QA representative in manufacturing process validations activities.
• As a member of Final Release Board release/reject final products
• Ensure quality of manufactured products by following HemoCue QMS procedures and work instructions and report quality related issues
• Support the organization regarding Supplier Management and QA related to Operations
• Support development projects regarding design transfer
• Review and approval of investigations, material disposition and required actions regarding NCRs.

The essential requirements of the job include:

• University Degree in Science or Technology
• Minimum 5 years of experience from Quality Management Systems.
• Minimum 3 years of management experience or proven leadership personality.
• Knowledge (experience or external training) of applicable standards and regulations including but not limited to IVDR/IVDD, ISO 13485, Quality System Regulations for Medical Devices, and risk management for medical devices (ISO 14971)
• Communication skills (verbal as well as in writing). English language – fluent verbally and in writing, and preferable Scandinavian – fluent verbally and in writing.
• Responsible for Nonconformance Management (NCR) to ensure safe and efficient processes.
• Review and analyze quality performance data to identify trends and areas of improvement

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

• Collaborate with cross-functional teams to ensure quality throughout the product and operations processes
• Planning, execution and management of Supplier Audits and supplier qualifications
• Excellent problem-solving skills

HemoCue, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.At HemoCue we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for HemoCue can provide.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 .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.

Expected salary

Location

Ängelholm, Skåne

Job date

Sat, 07 Jun 2025 01:07:12 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsineu.net) you saw this job posting.