QA Engineer

Description

The company is a medical technology business with more than 72,000 staff in over 70 countries, working on better outcomes and experiences for patients.

The team is a mix of scientists, clinicians, developers, researchers and specialists from many backgrounds, all working toward better access to care.

This Quality Engineer role supports the quality management system (QMS) by handling controlled documents, training and corrective and preventive actions (CAPAs). You will help keep the company compliant with regulations, ready for inspection and effective in its quality work.

Responsibilities

• Maintain controlled quality documents and records under internal procedures and regulatory rules.
• Handle creation, review, approval, revision and archiving of documents in the electronic document management system.
• Track document lifecycle steps and make sure controlled documents are updated on time.
• Help users with document management tasks and answer system questions.
• Check that quality records are complete, accurate, traceable and ready for audit.
• Coordinate quality training programmes and track training compliance across the company.
• Help build and update training curricula and learning plans.
• Work with process owners so training matches regulatory and procedural requirements.
• Raise awareness of quality system requirements and compliance duties.
• Support CAPAs by tracking actions, following up and monitoring due dates.
• Gather documents, records and evidence for quality investigations.
• Prepare quality metrics and reports on investigations, CAPAs and overall quality system performance.

Requirements

• Bachelor's degree in Quality Management, Engineering, Life Sciences, Business Administration or a related field.
• Experience in quality systems, document control, training management, CAPAs or a related quality function.
• Knowledge of standards such as ISO 13485, MDR and MDSAP.
• Familiarity with document control, records management and training administration.
• Experience in a regulated environment, preferably in healthcare, medical devices or a similar industry.
• A process- and compliance-minded approach, with attention to detail and accuracy.
• Strong coordination, organisation and follow-up skills.
• Ability to handle several priorities while keeping output at a high standard.
• Strong communication and collaboration skills across functions.

Conditions

Equal opportunity employer that welcomes applications from people with disabilities.