QA Engineer responsible for supporting testing activities of telephony software solutions at Saab, ensuring quality standards before deployment. Collaborating with development teams and influencing design decisions throughout product lifecycle.
About the role
- Sr QA Specialist overseeing NC CAPA processes in regulated MedTech environment. Collaborating with stakeholders and supporting investigations while ensuring compliance and quality management.
Responsibilities
- Support NC/CAPA system and process user training
- Facilitate the initiation of investigations and CAPAs and monitor progress to ensure timely completion
- Execute quality reviewer/approver duties, review evidence, and approve closure of NC and CAPA records
- Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures
- Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level
- Use data analytics and trending to identify failure modes, measure CAPA effectiveness, and inform continuous improvement priorities
- Collaborate with stakeholders, site owners, governance bodies, and senior management to resolve issues and align on corrective actions
Requirements
- Bachelor’s Degree in Life Science or related discipline or equivalent is required
- Minimum of 6 years’ experience in a regulated MedTech or Pharmaceutical Quality Systems Compliance field and/or equivalent experience/training in a related NC CAPA Investigation Quality System area
- Demonstrated experience as an investigator of Non-Conformance/CAPA process
- Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence
- Requires critical analytical and problem-solving skills, strategic thinker, and collaborator
- Ability to build consensus, influence, and negotiate
- Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices
Benefits
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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