QA Operations Specialist: Drive Quality Impact

HemoCue; Ängelholms kommun; Presencial; SEK 420 000 - 560 000; Tempo integral

Resumo da oferta

HemoCue, a leading provider of point-of-care diagnostic solutions, is seeking a QA Operation Specialist to ensure continuity in supplier quality management within RAQA. This on-site role at HemoCue HQ in Ängelholm collaborates with Operations, Quality Control and other functions to uphold quality across the organization.

You will support supplier qualification, audits, deviations and CAPAs, contribute to maintenance of the Quality Management System and participate in internal audits and

Qualificações

• Experience in QA, preferably including Supplier Quality.
• Basic understanding of regulatory requirements – GMP, ISO 13485, ISO 27001.
• Experience working with QMS is an advantage.
• Strong analytical skills and a structured way of working.

Responsabilidades

• Support supplier qualification, evaluation and monitoring activities.
• Plan, conduct and follow up on supplier audits.
• Manage supplier-related deviations, complaints and CAPAs.
• Support day-to-day QA activities across the organization.
• Contribute to maintenance and improvement of the Quality Management System.
• Participate in internal audits and regulatory inspections.
• Review and approve quality documentation.
• Support training activities and ensure process compliance.
• Contribute to change control and risk management processes.
• Support QA Release activities and act as QA Release Specialist when qualified and authorized.

Conhecimentos

QA experience

Regulatory understanding

Analytical skills

Bilingual English/Swedish

Formação académica

University degree in life sciences/engineering

Ferramentas

QMS

Descrição da oferta de emprego

HemoCue, a leading provider of point-of-care diagnostic solutions, is seeking a QA Operation Specialist to ensure continuity in supplier quality management within RAQA. This on-site role at HemoCue HQ in Ängelholm collaborates with Operations, Quality Control and other functions to uphold quality across the organization.

You will support supplier qualification, audits, deviations and CAPAs, contribute to maintenance of the Quality Management System and participate in internal audits and