Overview As a Senior Quality Engineer at Getinge, you will lead quality planning and ensure robust quality systems to support life-saving technology. You will collaborate with Manufacturing, QA, R&D, and engineering management to drive improvements, investigations, and validations. Your work enables compliant processes and effective CAPA, with a focus on delivering reliable products and safe patient outcomes. This role offers hands-on leadership in a global, mission-driven environment where quality underpins every action.
Compensation / Benefits- annual bonus 10%
- hybrid work arrangement
Responsibilities- Lead quality planning and ensure timely, effective plans and gap assessments
- Oversee quality management activities including CAPA and timely closure of corrective actions
- Run Material Review Board meetings and escalate non-conforming material issues
- Support supplier management and incoming material inspection
- Coordinate validations, protocol development, and interdepartmental alignment
- Review/approve qualification/validation and change control documentation
- Identify and implement process improvements in QA, manufacturing, and testing
- Mentor engineers and interns and provide training and guidance
- Lead health and hazard evaluation data gathering and analysis for Field Action Committee
- Lead and support CAPA activities and assist in failure investigations (NCMR)
Key requirements- Bachelor's degree in engineering, science or equivalent
- MS in Engineering/Science preferred
- CQE or CQA desirable
- 5+ years in quality assurance/engineering or MS + 3 years experience
- FDA-regulated industry or ISO-certified experience
- Strong statistical analysis and problem-solving skills
- Experience in quality systems and audits
- Project management and leadership experience
- Effective cross-department communication and influencing abilities
- Proficiency in Microsoft Office and analytical software applications
- communication across departments
- leadership and mentoring
- problem solving and analytical thinking
- statistical analysis
- quality systems
- CAPA
